Lingo 77263Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00357599848002), received between Nov 22, 2024 and Aug 21, 2026 — classified as 23 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  The customer experienced bleeding after inserting the Abbott Diabetes Care (ADC) device. The customer experienced symptoms such as edema as pain and was able to self-treat with Aspirin (antiplatelet). The ADC device was reported to be applied on an incorrect site instead of back of arm thus application being off label use. No third-party medical treatment/medication was provided. There was no report of death or permanent impairment associated with this event.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 50383678 ↗
• InjuryAug 20, 2026Low Readings

  A low reading issue with the Abbott Diabetes Care (ADC) device was reported. The customer received an unspecified lower scan result on the ADC device compared to an unspecified reading obtained on an unknown device. It is unknown whether the customer noted a trend arrow on the device. The customer experienced symptoms such as "feeling tired" and was able to self-treat with foods. Subsequently, the customer was seen at the hospital and further reported receiving third-party treatment from a healthcare professional (HCP) however, details of the treatment for the diagnosis of hyperglycemia were not provided. There was no report of death or permanent impairment associated with this event.

  Patient problems: Hyperglycemia

  MAUDE report 50347141 ↗
• MalfunctionJul 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105225 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  An adverse skin reaction was reported during wear of the Abbott Diabetes Care (ADC) device. The customer experienced symptoms described as bruising at the sensor site following application of the ADC device and self-treated with topical Polysporin cream to the affected area. There was no report of death or permanent impairment associated with this event.

  Patient problems: Bruise/Contusion; Skin Infection

  MAUDE report 50012214 ↗
• MalfunctionJul 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 75.00 mg/dL compared to readings of 210.00 mg/dL respectively obtained on a Lingo Glucose and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 1 day. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25905996 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  An adverse skin reaction was reported with wear of the Abbott Diabetes Care (ADC) device. The customer experienced skin infection described as "pain and nausea" and was treated with oral antibiotics (unspecified) by a third-party. There will be follow up visits for wound checks. There was no report of death or permanent impairment associated with this event.

  Patient problems: Nausea; Pain; Skin Infection

  MAUDE report 25466417 ↗
• MalfunctionJun 4, 2026Product Quality Problem

  A CUSTOMER REPORTS "VISABLE FIRE" FROM THEIR ABBOTT DIABETES CARE DEVICE. THE CUSTOMER FURTHER DETAILED THAT THEIR DEVICE, "FIRED BEFORE IT GOT TO HIS ARM." NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO REPORT OF SMOKE, EXPLOSION, OR SHOCK. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399681 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER EXPERIENCED BLEEDING AFTER INSERTION OF THE ABBOTT DIABETES CARE (ADC) BIOSENSOR. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS, NUT NO THIRD-PARTY TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 25176937 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER EXPERIENCED BLEEDING AFTER INSERTING THE ABBOTT DIABETES CARE (ADC) SENSOR. THE CUSTOMER WAS UNABLE TO SELF-TREAT REQUIRED UNSPECIFIED CREAM, GAUZE AND A TAPE FROM THE THIRD-PARTY FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25094556 ↗
• InjuryMay 3, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED OF PAIN AFTER 2 DAYS OF WEARING THE ABBOTT DIABETIC CARE (ADC) DEVICE. CUSTOMER EXPERIENCED DIZZINESS AND FAINT FEELING. HOWEVER, FURTHER FOLLOW-UP ATTEMPTS TO DETERMINE IF THERE WAS A LOSS OF CONSCIOUSNESS HAVE BEEN UNSUCCESSFUL. IT WAS UNKNOWN IF THE CUSTOMER RECEIVED ANY TREATMENT FROM THIRD-PARTY ADMINISTRATION FOR THE REPORTED PRODUCT ISSUE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Dizziness; Pain

  MAUDE report 25062768 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED ITCHING AT THE SENSOR SITE AND SELF-TREATED WITH UNSPECIFIED AGENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 25046709 ↗
• InjuryApr 10, 2026Low Readings

  A CUSTOMER REPORTED BIOSENSOR DISPLAYING READINGS OF 55 MG/DL AND IT IS UNKNOWN WHETHER THE CUSTOMER NOTED A TREND ARROW ON THE DEVICE. THE CUSTOMER EXPERIENCED ANXIETY AND IT IS UNKNOWN WHAT TYPE OF THIRD-PARTY TREATMENT, IF ANY, THE CUSTOMER SOUGHT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Anxiety

  MAUDE report 24839818 ↗
• MalfunctionApr 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER RECEIVED AN ADC DEVICE SCAN RESULT OF 40.0 MG/DL COMPARED TO READING OF 150.0 MG/DL RESPECTIVELY OBTAINED ON AN ADC METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS UNKNOWN. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795059 ↗
• InjuryApr 1, 2026Delivered as Unsterile Product; Unsealed Device Packaging

  A TAMPERED-PACKAGING ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE VIA EMAIL. THE CUSTOMER REPORTED RECEIVING DEVICES ORDERED THROUGH AMAZON THAT APPEARED TO BE PREVIOUSLY USED. UPON REMOVING THE PLASTIC WRAP, THE CUSTOMER NOTED THAT THE PRODUCT BOXES WERE OPEN, AND THE DEVICES FELL OUT, RESULTING IN AN UNSPECIFIED INJURY. THE CUSTOMER STATED THAT THE DEVICES WERE NOT SAFETY-SEALED AND APPEARED CONTAMINATED OR DAMAGED. THE CUSTOMER CONSULTED A HEALTHCARE PROFESSIONAL (HCP); HOWEVER, NO TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24756525 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED A SKIN INFECTION WITH SYMPTOMS DESCRIBED AS "RED AREA" AT THE ADC DEVICE INSERTION SITE. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO PRESCRIBED UNSPECIFIED ANTIBIOTICS FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Erythema; Skin Infection

  MAUDE report 24722129 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS SWELLING, REDNESS, AND "SKIN WAS HOT". THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO CHECKED THE CUSTOMERS VITALS, MARKED THE AREA TO VERIFY IT DID NOT GROW, AND PRESCRIBED ANTIBIOTICS FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Erythema; Skin Infection; Swelling/ Edema

  MAUDE report 24627369 ↗
• MalfunctionDec 9, 2025Delivered as Unsterile Product; Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Delivered as Unsterile Product; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED PRIOR TO USE THEY OBSERVED THEIR" BIOSENSOR DAMAGE" WITH USE OF THE ABBOTT DIABETES CARE (ADC) DEVICE AND WAS NOT RECEIVED IN STERILE CONDITION. IN ADDITION, THE CUSTOMER STATED, "THERE WAS BROWN SUBSTANCE ON THE TOP." THERE WAS NO INDICATION THAT THE CUSTOMER APPLIED THE DEVICE TO THEIR BODY, AND NO PATIENT CONSEQUENCES WERE REPORTED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753915 ↗
• InjuryDec 5, 2025High Readings; High Readings

  A HIGH READINGS ISSUE WITH THE ABBOTT DIABETES CARE (ADC) LINGO GLUCOSE SYSTEM WAS REPORTED. THE CUSTOMER RECEIVED UNSPECIFIED HIGHER SENSOR SCAN RESULTS COMPARED TO HOW THE CUSTOMER WAS FEELING. IT IS UNKNOWN WHETHER THE CUSTOMER NOTED A TREND ARROW ON THE DEVICE. THE CUSTOMER EXPERIENCED, ANXIETY, DIZZINESS, MOOD SWINGS, AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND REQUIRED TREATMENT OF ORANGE JUICE AND GLUCOSE TABLETS ADMINISTERED BY A HEALTHCARE PROFESSIONAL (HCP) FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Anxiety; Cognitive Changes; Dizziness; Hypoglycemia; Loss of consciousness

  MAUDE report 23729573 ↗
• MalfunctionNov 27, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  A CUSTOMER REPORTED A PACKAGING ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND STATED: "CASE OF A SENSOR THAT HAD THE FILAMENT OUTSIDE OF THE COVER." THERE WAS NO INDICATION THAT THE CUSTOMER APPLIED THE DEVICE TO THEIR BODY, AND NO PATIENT CONSEQUENCES WERE REPORTED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666148 ↗
• InjuryNov 7, 2025Failure to Power Up; Failure to Power Up

  ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION PERTAINING TO AN ABBOTT DIABETES CARE (ADC) DEVICE: "I RECEIVED THE ABBOTT LINGO PRODUCT ON (B)(6) 2025 AND PROMPTLY ATTACHED IT TO MY BODY. WITHIN THE FIRST 2 HOURS, THE PRODUCT WAS EXPERIENCING BLUETOOTH CONNECTIVITY ISSUES. IT WOULD NOT STAY CONNECTED FOR MORE THAN 8-10 HOURS PER DAY (IT IS SUPPOSED TO BE CONNECTED 24 HOURS PER DAY). ON DAY 4, THE DEVICE COMPLETELY FAILED AND I RECEIVED A NOTIFICATION FROM THE APP TO REPLACE THE DEVICE. ABBOTT ADVERTISES THAT THE DEVICE SHOULD LAST 14 DAYS, SO A FAILURE AFTER 4 DAYS OF NORMAL USE WAS CONCERNING. CUSTOMER SERVICE FROM ABBOTT HAS NOT BEEN HELPFUL WITH FIXING OR REPLACING THE DEVICE." BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503657 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABBOTT DIABETES CARE (ADC) RECEIVED A COMPLAINT VIA EMAIL. A CUSTOMER REPORTED THAT WHILE USING THE LINGO GLUCOSE BIOSENSOR, THEY EXPERIENCED SEVERE IRRITATION AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED MUPIROCIN CREAM. THE CUSTOMER MENTIONED THAT THEY APPLIED THE CREAM FROM OCTOBER 2 TO OCTOBER 4, 2025, AND NOTED AN IMPROVEMENT IN THE CRUSTY BUMPS AFTER THREE DAYS OF USE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 23478652 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED SEVERE SKIN IRRITATION AND A LARGE, PALPABLE BUMP AT THE INSERTION SITE. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO DIAGNOSED THEM WITH CELLULITIS AND PROVIDED UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23470644 ↗
• MalfunctionAug 28, 2025Unintended Electrical Shock; Unintended Electrical Shock

  A CUSTOMER REPORTS ELECTRIC SHOCK ON THE FIFTH DAY OF WEAR, WHILE WEARING AN ABBOTT DIABETES CARE DEVICE. THERE WAS NO REPORT OF FIRE, SMOKE, OR EXPLOSION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916347 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) LINGO GLUCOSE SYSTEM. THE CUSTOMER REPORTED EXPERIENCING REDNESS AND DISCOMFORT AT THE INSERTION SITE AND WAS ABLE REMOVED THE SENSOR HOWEVER, THE SYMPTOMS WORSENED A DAY LATER. THE CUSTOMER PRESENTED TO URGENT CARE WHERE A HEALTHCARE PROFESSIONAL (HCP) DIAGNOSED THE CUSTOMER WITH CELLULITIS AND PRESCRIBED ORAL ANTIBIOTICS. THE CUSTOMER LATER SELF-PRESENTED AT THE EMERGENCY WITH ADDITIONAL DESCRIBED AS OF "WARMTH", SWELLING, AND PAIN AT THE INSERTION SITE. AN "EXAM AND ULTRASOUND" WERE CONDUCTED, REVEALING AN ABSCESS FORMATION. AN INCISION AND DRAINAGE PROCEDURE WERE PERFORMED TO DRAIN THE ABSCESS. THE CUSTOMER FURTHER PROVIDED ANTIBIOTICS WITH FOLLOW-UP INSTRUCTIONS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Abscess; Discomfort; Erythema; Pain; Purulent Discharge; Skin Infection; Swelling/ Edema

  MAUDE report 22754326 ↗
• InjuryAug 8, 2025Packaging Problem; Packaging Problem

  ABBOTT DIABETES CARE (ADC) RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: A CUSTOMER REPORTED THAT WHILE USING THE LINGO GLUCOSE SYSTEM, THEY ENCOUNTERED DIFFICULTY IN REMOVING THE SENSOR AND THERE WERE NO PROPER INSTRUCTIONS FOR USE ON HOW TO REMOVE THE LINGO GLUCOSE SENSOR. BEFORE TRYING TO REMOVE THE SENSOR, THEY VISITED THE MANUFACTURER'S WEBSITE AND FOUND AN ARTICLE OUTLINING THE REMOVAL PROCESS. HOWEVER, WHEN THEY ATTEMPTED TO REMOVE THE DEVICE, THEY STATED "STRUGGLED TO SECURE THE EDGE OF THE DOUBLE-SIDED ADHESIVE TAPE WITH THEIR FINGERS BECAUSE THERE WAS INSUFFICIENT TAPE EXPOSED FOR A FIRM GRIP. THE CUSTOMER ALSO EXPRESSED ANXIETY ABOUT WHETHER THE SKIN-PIERCING SENSOR TIP COULD BE REMOVED COMPLETELY AND SAFELY." ADC CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER THREE TIMES TO GAIN ADDITIONAL DETAILS REGARDING THIS EVENT; HOWEVER, ALL FOLLOW UP ATTEMPTS WERE UNSUCCESSFUL. THE CUSTOMER DID NOT RECEIVE ANY MEDICAL TREATMENT. THERE WAS NO REPORT OF AN ADVERSE EVENT OR THIRD-PARTY INTERVENTION RELATED TO THIS ISSUE. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Anxiety

  MAUDE report 22751347 ↗