FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0118Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00815381020123), received between Jan 12, 2017 and Sep 22, 2026 — classified as 6 deaths, 24 injuries.

The most frequently reported specific device problem is “False Positive Result” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026False Positive Result

  Summary: The customer (Muscat, Oman) reported a potential false positive Escherichia coli K1 (E. coli K1) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient CSF sample. The customer reported that due to the ME Panel result, the patient was indirectly impacted, specifically by inappropriate treatment, which might lead to serious injury if it were to recur. The customer stated that the patient was not harmed. BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854377 ↗
• InjurySep 10, 2026False Positive Result

  Summary:(b)(6) l "[Canada]" reported a potential false positive H. influenzae result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient cerebrospinal fluid sample. The customer reported that due to the ME panel result, that patient was indirectly impacted, specifically through unnecessary antibiotic treatment, which might lead to serious injury if it were to recur. No patient harm was reported.BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714236 ↗
• InjurySep 9, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701517 ↗
• InjurySep 9, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699610 ↗
• InjurySep 9, 2026False Positive Result

  Summary:(b)(6) "[France]" reported a potential false positive VZV result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient cerebrospinal fluid sample. The customer reported that due to the ME panel result, that patient was indirectly impacted, specifically inappropriately treated with Acyclovir from (b)(6) 2026, which might lead to serious injury if it were to recur. No patient harm was reported.BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689824 ↗
• InjurySep 4, 2026False Positive Result

  Summary:(b)(6) HOSP - (b)(6) USA) reported a false positive Varicella Zoster Virus (VZV) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient cerebrospinal fluid (CSF) sample from a 6 month old male patient. The customer reported that due to the ME Panel result, the patient was indirectly impacted, specifically inappropriate treatment with acyclovir, which might lead to serious injury if it were to recur. No patient harm was reported. BioFire has requested further information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614575 ↗
• InjurySep 2, 2026False Positive Result

  Summary:The customer (b)(6) reported a potential false positive Varicella zoster virus (VZV) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient CSF sample. The customer reported that due to the ME Panel result, that patient was indirectly impacted, specifically initiation of acyclovir that was likely unnecessary, which might lead to serious injury if it were to recur. No patient harm was reported.The investigation concluded that the most likely cause of the VZV discrepant result was due to low level contamination.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570510 ↗
• InjuryAug 6, 2026False Negative Result

  Summary: The customer ((b)(6) Mexico) reported a potential false negative Cryptococcus neoformans/gattii (C. neoformans/gattii) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a CSF sample from an 85-year-old male patient. The customer reported that due to the ME Panel result, that patient was indirectly impacted, specifically by a delay in treatment of approximately one day, which might lead to serious injury if it were to recur. No patient harm was reported, however it was reported the patient later expired for reasons unrelated to the ME Panel result. The investigation concluded that the most likely cause for the discrepant Cryptococcus results was comparator sensitivity/specificity differences between the ME Panel and traditional laboratory methods.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161312 ↗
• InjuryAug 6, 2026False Positive Result

  Summary:The customer (Clamart, France) reported a potential false positive E. coli K1 result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a CSF patient sample. The customer reported that due to the ME Panel result, that patient was indirectly impacted, specifically an escalation of intravenous antibiotic therapy, which might lead to serious injury if it were to recur. No patient harm was reported.The investigation concluded that the most likely cause of the false positive E. coli K1 result was contamination.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157218 ↗
• InjuryAug 5, 2026False Negative Result

  Summary:The customer ((b)(6) Australia) reported a potential false negative Neisseria meningitidis (N. meningitidis) result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient CSF sample. The customer reported that due to the ME Panel result, that patient was indirectly impacted, specifically delayed/interrupted treatment, which might lead to serious injury if it were to recur. Patient harm is unknown. Based on the information provided, the investigation concluded that the most likely cause of the erroneous N. meningitidis result was sensitivity/specificity differences between the ME Panel and comparator methods with a low-level analyte near the limit of detection (LoD) of the FilmArray system.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145006 ↗
• InjuryAug 5, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139323 ↗
• InjuryJul 31, 2026False Positive Result

  Summary:SPSK NR. 1 ((b)(6), Poland) reported a false positive S. agalactiae and HHV-6 result on the FilmArray® Meningitis/Encephalitis (ME) Panel after testing a patient cerebrospinal fluid (CSF) sample. Due to the ME Panel result, the patient may have received inappropriate treatment. No patient harm was reported. BioFire has requestedfurther information from the customer and is currently investigating this event. No remedial action, corrective action, preventive action, or field safety corrective action (FSCA) has been deemed necessary at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105690 ↗
• InjuryJul 30, 2026False Positive Result

  Summary:The customer (Aalst, Belgium) reported a false-positive HSV-1 result on the FilmArray Meningitis/Encephalitis (ME) Panel after testing a patient CSF sample. The customer reported that due to the ME Panel result, the patient was treated inappropriately with acyclovir for two days. They subsequently stated that the patient suffered no other harm and did not deteriorate due to the erroneous BioFire result. The investigation concluded that the most likely causes of the potential false-positive result were low-level organism/nucleic acid present within the sample near the BIOFIRE Limit of Detection (LoD) or contamination.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092758 ↗
• InjuryFeb 12, 2026False Negative Result

  (B)(6). PUBLISHED A STUDY, "(B)(6)" WHICH DESCRIBES A POTENTIAL FALSE NEGATIVE HSV-1 AND A POTENTIAL FALSE NEGATIVE HHV-6 ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL DURING TESTING OF A CSF SAMPLE FROM A 20-MONTH-OLD MALE PATIENT. THE PUBLICATION SUGGESTED THAT THE BIOFIRE RESULT LED TO PREMATURE DISCONTINUATION OF ACYCLOVIR, WHICH CONTRIBUTED TO NEUROLOGICAL SEQUELAE, INCLUDING SPASTIC QUADRIPARESIS AND FUNCTIONAL DEPENDENCE. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE AUTHOR AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME. UPDATE FOR SUPPLEMENTAL REPORT: UPON FOLLOWING WITH THE AUTHORS, THEY INDICATED THE STUDY SAMPLE WAS FROM OVER A YEAR AGO. THE FIRST FILMARRAY RESULT WAS FROM ANOTHER CLIENT (FUNDACIÓN CLUB NOEL), BUT THE CHILD HAD BEEN EXPERIENCING SYMPTOMS FOR LESS THAN 24 HOURS, SO THE POSSIBILITY OF A FALSE NEGATIVE WAS VERY HIGH. THE PATIENT DID NOT REQUIRE ANY FURTHER INTERVENTION AND SUFFERED NO LASTING EFFECTS FROM DISCONTINUING THE TREATMENT. BIOFIRE IS STILL INVESTIGATING THIS EVENT IN ORDER TO DETERMINE THE ROOT CAUSE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24325009 ↗
• DeathJan 16, 2026False Negative Result

  LEONG ET AL. PUBLISHED A STUDY "A LETHAL CASE OF CRYPTOCOCCAL MENINGITIS IN AN APPARENTLY IMMUNOCOMPETENT PATIENT: A CASE REPORT HIGHLIGHTING DIAGNOSTIC PITFALLS AND THERAPEUTIC CHALLENGES," WHICH DESCRIBES A POTENTIAL FALSE NEGATIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL DURING PATIENT TESTING. THE PUBLICATION SUGGESTED THAT THE BIOFIRE RESULT MAY HAVE DIRECTLY CONTRIBUTED TO A DELAY IN DIAGNOSIS. THE PUBLICATION FURTHER CLAIMED THAT THE DIAGNOSTIC DIFFICULTIES ENCOUNTERED WITH THIS PATIENT EVENTUALLY LEAD TO THE DELAYED DIAGNOSIS AND MORTALITY. THE AUTHORS WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING PATIENT IMPACT. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE POTENTIAL FALSE NEGATIVE RESULT WAS LOW-LEVEL ORGANISM/NUCLEIC ACID WITHIN THE SAMPLE WHICH WAS NEAR/BELOW THE LIMIT OF DETECTION (LOD) FOR THE BIOFIRE ME PANEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092407 ↗
• InjuryJan 6, 2026False Negative Result

  SUMMARY: (B)(6) HOSPITAL COMPLEX OF (B)(6) REPORTED A POTENTIAL FALSE-NEGATIVE CRYPTOCOCCUS RESULT ON THE FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CSF SAMPLE FROM A 73-YEAR-OLD FEMALE PATIENT. THE CUSTOMER REPORTED THAT THE ERRONEOUS ME PANEL RESULTS CAUSED/CONTRIBUTED TO A DELAY IN THE PATIENT'S DIAGNOSIS AND TREATMENT. THEY ALSO REPORTED THAT THE PATIENT DETERIORATED DUE TO THIS DELAY. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT CRYPTOCOCCUS RESULT WAS COMPARATOR SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE ME PANEL, CRYPTOCOCCAL ANTIGEN (CRAG) TESTING, AND CSF CULTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980417 ↗
• InjuryNov 25, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6), (VIETNAM) REPORTED A POTENTIAL FALSE NEGATIVE ESCHERICHIA COLI K1 (E. COLI K1) RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CSF SAMPLE FROM A 67-YEAR-OLD, FEMALE PATIENT. THE PATIENT WAS NOT AFFECTED DUE TO THE DISCREPANT ME PANEL RESULT. THE CUSTOMER HAD INITIALLY COMMUNICATED THAT THAT THE PATIENT'S TREATMENT WAS DELAYED, THE PATIENT WAS HARMED, AND THE PATIENT WAS IN COMA AND RECEIVING MECHANICAL VENTILATION. IT WAS UNCLEAR WHETHER THE PATIENT¿S COMA AND NEED FOR MECHANICAL VENTILATION WERE RELATED TO THE ME PANEL RESULT; THEREFORE, AN INITIAL REPORT WAS SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. HOWEVER, THE CUSTOMER LATER CLARIFIED THAT THE PATIENT'S TREATMENT WAS NOT AFFECTED DUE TO THE ME PANEL. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT E. COLI K1 RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE ME PANEL AND CULTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648742 ↗
• InjuryNov 19, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) MEDICAL CENTER (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT¿S CEREBROSPINAL FLUID (CSF) SAMPLE. DUE TO THE FILMARRAY ME PANEL RESULT, THERE WAS A 13-DAY DELAY IN REPORTING RESULTS, AND THE PATIENT DETERIORATED DUE TO THE DELAY. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE C. NEOFORMANS/GATTII DISCREPANT RESULT WAS DUE TO SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AND TRADITIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600759 ↗
• DeathNov 6, 2025False Negative Result; False Negative Result

  SUMMARY: HOSPITAL (B)(6), REPORTED SEVERAL POTENTIAL FALSE NEGATIVE HSV-1 RESULTS ON THE ME PANEL AFTER TESTING MULTIPLE CSF SAMPLES FROM A 79-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS TREATED INAPPROPRIATELY AS TREATMENT WITH ACICLOVIR WAS STOPPED FOR THREE DAYS. THE PATIENT LATER DIED. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485028 ↗
• DeathMar 12, 2025False Negative Result; False Negative Result

  SUMMARY: (B)(6) HÔPITAL (QUEBEC, CANADA) REPORTED A POTENTIAL FALSE NEGATIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT'S CEREBROSPINAL FLUID (CSF) SAMPLE. DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT'S DIAGNOSIS AND TREATMENT WAS DELAYED. THE CUSTOMER REPORTED THAT THE PATIENT PASSED AWAY AND THEIR DEATH APPEARED TO BE MULTIFACTORIAL, BUT THE DIAGNOSTIC DELAY POSSIBLY CONTRIBUTED TO THE UNFAVORABLE OUTCOME FOR THE PATIENT. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE FILMARRAY ME PANEL WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT C. NEOFORMANS/GATTII RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY ME PANEL AND TRADITIONAL LABORATORY METHODS.

  Patient problems: Insufficient Information

  MAUDE report 21589786 ↗
• InjuryDec 13, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE POSITIVE VARICELLA ZOSTER VIRUS (VZV) RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE. DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT RECEIVED INAPPROPRIATE TREATMENT. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT VZV RESULT WAS 1) SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY ME PANEL AND THE COMPARATOR PCR METHOD WITH A LOW-LEVEL ANALYTE OR 2) CONTAMINATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931510 ↗
• DeathNov 21, 2024False Negative Result; False Negative Result

  SUMMARY: A PUBLICATION BY HOANG TITLED "THE DECEPTIVE REASSURANCE OF A "NEGATIVE" TEST- A DIFFICULT CASE HIGHLIGHTING THE BIOFIRE MENINGITIS/ENCEPHALITIS PANEL AND MEDICAL HEURISTICS" DESCRIBED TWO FALSE NEGATIVE LISTERIA MONOCYTOGENES RESULTS ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CEREBROSPINAL FLUID (CSF) FROM A 69-YEAR-OLD, MALE PATIENT. THE AUTHOR REPORTED THAT DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE TREATMENT, WHICH LED TO THE SPREAD OF BACTERIA AND CAUSING THE PATIENT TO BE IN A VEGETATIVE STATE. THE PATIENT THEN PASSED AWAY YEAR AND HALF LATER. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Coma

  MAUDE report 20750039 ↗
• InjuryOct 9, 2024False Positive Result; False Positive Result

  SUMMARY: MIOMED S.A.S REPORTED A POTENTIAL FALSE POSITIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT AFTER TESTING A CEREBROSPINAL FLUID (CSF) SAMPLE FROM A 67-YEAR-OLD MALE PATIENT. DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT WAS TREATED WITH AMPHOTERICIN B, WHICH MAY HAVE LED TO PATIENT KIDNEY FAILURE. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT RESULT WAS CONTAMINATION.

  Patient problems: Renal Failure

  MAUDE report 20412863 ↗
• InjurySep 6, 2024False Positive Result; False Positive Result

  SUMMARY: (B)(6) MEDICINE ((B)(6), WA) REPORTED A POTENTIAL FALSE POSITIVE VARICELLA ZOSTER VIRUS (VZV) RESULT ON FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CEREBROSPINAL FLUID (CSF) SAMPLE FROM A 24-YEAR-OLD FEMALE PATIENT. DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT WAS TREATED WITH ACYCLOVIR FOR 48 HOURS AND THE PATIENT'S CONDITION DETERIORATED. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE FILMARRAY ME PANEL WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT VZV RESULT WAS 1) SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY ME PANEL AND THE IN-HOUSE PCR COMPARATOR METHOD OR 2) CONTAMINATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162144 ↗
• InjuryMar 2, 2020False Positive Result; False Positive Result

  (B)(6) REPORTED A DISCREPANT CRYPTOCOCCUS NEOFORMANS/GATTII (C. NEOFORMANS/GATTII) RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CEREBROSPINAL FLUID (CSF) SAMPLE FROM A (B)(6) YEAR-OLD, MALE PATIENT. DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT RECEIVED INAPPROPRIATE TREATMENT FOR AN UNKNOWN PERIOD OF TIME. WHEN ASKED IF THE PATIENT WAS HARMED, THE CUSTOMER RESPONDED "POSSIBLY." ATTEMPTS TO RECEIVE CLARIFICATION OF THIS STATEMENT AND FURTHER EVENT DETAILS HAVE BEEN UNSUCCESSFUL. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE FILMARRAY ME PANEL SYSTEM WAS PERFORMING WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSES FOR THE DISCREPANT RESULT ARE SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY ME PANEL AND COMPARATOR METHODS WHEN TESTING A SAMPLE WITH LOW LEVELS OF ORGANISM, OR CONTAMINATION.

  Patient problems: No Information

  MAUDE report 9777456 ↗