Verigene® Processor SP 10-0000-07 (UDI 00840487101483)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840487101483), received between May 4, 2022 and Aug 4, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Output Problem” (13 reports).

3 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 18, 2021Open, Classified

   Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

   Z-1488-2021 · Root cause: Process control · FDA record ↗

2. Jun 15, 2020Terminated

   An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

   Z-2775-2020 · Root cause: Device Design · FDA record ↗

3. Jun 15, 2020Terminated

   An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

   Z-2776-2020 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Failure of Device to Self-Test

  THE SERVICE VISIT AT KAISER PERMANENTE REGIONAL REFERENCE LAB - (B)(4) WAS SCHEDULED FOR A 12 MONTH PM WITHIN WORK ORDER: (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTIONS 7 AND 8 WERE UPDATED TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170053 ↗
• MalfunctionJun 15, 2022Output Problem

  THE SERVICE VISIT AT CRISP REGIONAL HOSPITAL WAS SCHEDULED PER (B)(4)WITHIN WORK ORDER (B)(6). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838).

  Patient problems: Insufficient Information

  MAUDE report 14700507 ↗
• MalfunctionJun 15, 2022Output Problem

  THE SERVICE VISIT AT MARIETTA MEMORIAL HOSPITAL WAS SCHEDULED PER CAPA-(B)(4) WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT ((B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 14700348 ↗
• MalfunctionJun 15, 2022Output Problem

  THE SERVICE VISIT AT (B)(6) MEDICAL CENTER WAS SCHEDULED PER CAPA (B)(4) WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14700333 ↗
• MalfunctionJun 13, 2022Output Problem

  THE VISIT AT GRAND STRAND REGIONAL MEDICAL CENTER LLC WAS SCHEDULED PER (B)(4) WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINTS 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT ((B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 14681890 ↗
• MalfunctionMay 11, 2022Output Problem

  THE SERVICE VISIT AT (B)(6) MEDICAL CENTER WAS SCHEDULED PER CAPA (B)(4) WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838). DATA REVIEW: PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768),THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE HYB HEATER HAS AN UPPER AND LOWER TOLERANCE OF +/-2 DEGREE CELSIUS FROM THE SETPOINT TEMPERATURE 1 (38.5C) AND SETPOINT 2 (90C). IN REVIEWING THE NAPLOGS, SETPOINT 1 FOR THE HYB HEATER WAS WITHIN THE ACCEPTABLE TEMPERATURE RANGE VERIFICATION TESTING. PER THE VERIGENE PROCESSOR SP SYSTEM DESIGN FMEA (NAPIII-FMEA-1729), THE SYSTEM WILL MONITOR TEMPERATURE THROUGHOUT THE PROC

  Patient problems: Insufficient Information

  MAUDE report 14366005 ↗
• MalfunctionMay 11, 2022Output Problem

  THE SERVICE VISIT AT CARY MEDICAL CENTER WAS SCHEDULED PER CAPA(B)(4) WITHIN WORK ORDER (B)(6). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838). DATA REVIEW: PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768),THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE HYB HEATER HAS AN UPPER AND LOWER TOLERANCE OF +/-2 DEGREE CELSIUS FROM THE SETPOINT TEMPERATURE 1 (38.5C) AND SETPOINT 2 (90C). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 1 FOR THE HYB HEATER WAS WITHIN THE ACCEPTABLE TEMPERATURE RANGE VERIFICATION TESTING. PER THE VERIGENE PROCESSOR SP SYSTEM DESIGN FMEA (NAPIII-FMEA-1729), THE SYSTEM WILL MONITOR TEMPERATURE THROUGHOUT TH

  Patient problems: Insufficient Information

  MAUDE report 14365936 ↗
• MalfunctionMay 11, 2022Output Problem

  THE SERVICE VISIT AT METHODIST HOSPITAL - OMAHA WAS SCHEDULED PER CAPA-21-014 WITHIN WORK ORDER WO-00199593. DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838). DATA REVIEW. PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768),THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE HYB HEATER HAS AN UPPER AND LOWER TOLERANCE OF +/-2 DEGREE CELSIUS FROM THE SETPOINT TEMPERATURE 1 (38.5C) AND SETPOINT 2 (90C). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 1 FOR THE HYB HEATER WAS WITHIN THE ACCEPTABLE TEMPERATURE RANGE VERIFICATION TESTING. PER THE VERIGENE PROCESSOR SP SYSTEM DESIGN FMEA (NAPIII-FMEA-1729), THE SYSTEM WILL MONITOR TEMPERATURE THROUG

  Patient problems: Insufficient Information

  MAUDE report 14365919 ↗
• MalfunctionMay 9, 2022Output Problem

  THE SERVICE VISIT AT THE KAISER PERMANENTE REGIONAL LAB WAS SCHEDULED PER CAPA (B)(4)WITHIN WORK ORDER WO-00199891. DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINTS 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838). DATA REVIEW: PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768),THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE HYB HEATER HAS AN UPPER AND LOWER TOLERANCE OF +/-2 DEGREE CELSIUS FROM THE SETPOINT TEMPERATURE 1 (38.5C) AND SETPOINT 2 (90.0C). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 1 FOR THE HYB HEATER HAD AN ADJUSTED TEMPERATURE OF +39.1C, WITHIN THE RANGE ESTABLISHED IN 03838. HOWEVER; SETPOINT 2 HAD AN ADJUSTED TEMPERATURE OF +93.5C, 1.5C HIGHER THAN THE AC

  Patient problems: Insufficient Information

  MAUDE report 14342674 ↗
• MalfunctionMay 9, 2022Output Problem

  THE SERVICE VISIT AT THE UNIVERSITY OF MICHIGAN HOSPITAL WAS SCHEDULED PER CAPA-21-014 WITHIN WORK ORDER WO-00200141. DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINTS 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT ((B)(4)). DATA REVIEW PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768),THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE HYB HEATER HAS AN UPPER AND LOWER TOLERANCE OF +/-2 DEGREE CELSIUS FROM THE SETPOINT TEMPERATURE 1 (38.5C) AND SETPOINT 2 (90.0C). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 1 FOR THE HYB HEATER HAD AN ADJUSTED TEMPERATURE OF +39.4C, WITHIN THE RANGE ESTABLISHED IN 03838. HOWEVER, SETPOINT 2 HAD AN ADJUSTED TEMPERATURE OF +92.2C, 0.2C HIGHER THAN THE

  Patient problems: Insufficient Information

  MAUDE report 14342567 ↗
• MalfunctionMay 7, 2022Output Problem

  WHILE PERFORMING TSB LOG VERIFICATIONS PER FSA (B)(4) ON VERIGENE PROCESSOR SP INSTRUMENT (PN 10-0000-07R) S/N (B)(4), THE FSE NOTICED THE INCORRECTLY MARKED TSB LOG AFFIXED TO THE BACK OF THE INSTRUMENT. THE FSE SAW THAT TSB (B)(4) FOR AMP HEATER REPLACEMENTS WAS NOT COMPLETED BUT MARKED AS COMPLETED ON THE LOG. THE FSE VERIFIED THE ACCURACY OF THE TSB LOG PER FSA (B)(4) AND REPLACED THE TSB LOG. THE DISCREPANCY WAS DISCOVERED BY THE FSE DURING A TSB LOG VERIFICATION CHECK AT (B)(4). TECH SUPPORT CHANGED RISK ASSESSMENT QUESTION 4 TO 'YES' AS A RESULT OF THIS FOUND LABELING ISSUE. IT SHOULD BE NOTED A SIMILAR ISSUE WAS FOUND ON (B)(6) 2021 AND ESCALATION CASE (B)(4) WAS OPENED TO ADDRESS THIS ISSUE. THROUGH INVESTIGATION IT WAS FOUND THAT POTENTIALLY 300+ VERIGENE I SP'S MAY HAVE BEEN INCORRECTLY MARKED DUE TO TSB (B)(4), TSB LOG INSTALLATION FOR VERIGENE SP TECHNICAL SERVICE BULLETIN, NOT BEING EXECUTED PROPERLY. TO MITIGATE THE RISK OF INCORRECTLY MARKED TSB LOGS IN THE FIELD, FSA (B)(4), VERIGENE I PROCESSOR SP TSB CLARIFICATION FIELD SERVICE ADVISORY, WAS RELEASED FOR FIELD USE ON (B)(6) 2021. THIS FSA WAS CREATED TO PREVENT ANY CONFUSION AROUND TSB LOG INSTALLATION AND PROVID

  Patient problems: Insufficient Information

  MAUDE report 14323711 ↗
• MalfunctionMay 7, 2022Output Problem

  THE SERVICE VISIT AT THE UNIVERSITY OF WASHINGTON MEDICAL CENTER WAS SCHEDULED PER CAPA(B)(4) WITHIN WORK ORDER WO-00199657. DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838). DATA REVIEW PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768),THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE HYB HEATER HAS AN UPPER AND LOWER TOLERANCE OF +/-2 DEGREE CELSIUS FROM THE SETPOINT TEMPERATURE 1 (38.5C) AND SETPOINT 2 (90.0C). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 1 FOR THE HYB HEATER WAS WITHIN THE ACCEPTABLE TEMPERATURE RANGE VERIFICATION TESTING. PER THE VERIGENE PROCESSOR SP SYSTEM DESIGN FMEA (NAPIII-FMEA-1729), THE SYSTEM WILL MONITOR T

  Patient problems: Insufficient Information

  MAUDE report 14322319 ↗
• MalfunctionMay 6, 2022Output Problem

  THE SERVICE VISIT AT KATHERINE (B)(6) HOSPITAL. WAS SCHEDULED PER CAPA-21-014 WITHIN WORK ORDER WO-00199948. DURING THE SITE VISIT, THE ELUTION HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINTS 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT ((B)(4)). PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT ((B)(4)), THE STUDY EVALUATED THE ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN (B)(4), THAT THE ELUTION HEATER HAS A LOWER TOLERANCE OF -4DEGREE CELSIUS AND AN UPPER TOLERANCE OF GREATER THAN OR EQUAL TO 5DEGREE FROM THE SETPOINT TEMPERATURE 1 (75.0C) AND SETPOINT 2 (85.0C). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 1 FOR THE ELUTION HEATER HAD AN ADJUSTED TEMPERATURE OF +86.1C AND SETPOINT 2 HAD AN ADJUSTED TEMPERATURE OF +97.9C; BOTH HIGHER THAN THE ACCEPTABLE RANGE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311544 ↗
• MalfunctionMay 4, 2022Incorrect, Inadequate or Imprecise Result or Readings

  THE SERVICE VISIT AT BLANCHARD VALLEY HEALTH SYSTEM WAS SCHEDULED PER CAPA(B)(4) WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINTS 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838). DATA REVIEW PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768), THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE HYB HEATER HAS AN UPPER AND LOWER TOLERANCE OF +/-2 DEGREE CELSIUS FROM THE SETPOINT TEMPERATURE 1 (38.5DEGC) AND SETPOINT 2 (90DEGC). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 1 FOR THE HYB HEATER HAD AN ADJUSTED TEMPERATURE OF +39.4C, WITHIN THE RANGE ESTABLISHED IN 03838. HOWEVER, SETPOINT 2 HAD AN ADJUSTED TEMPERATURE OF +92.4C, 0.4C HIGHER THAN THE ACCEPTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274700 ↗
• MalfunctionMay 4, 2022Output Problem

  THE SERVICE VISIT AT SHARON REGIONAL HEALTH SYSTEM WAS SCHEDULED PER (B)(4) WITHIN WORK ORDER WO-00200058. DURING THE SITE VISIT, THE AMPLIFICATION (AMP) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 3. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838). PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768),THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE AMP HEATER HAS AN UPPER TOLERANCE OF +1 DEGREE CELSIUS FROM THE SETPOINT 3 TEMPERATURE 3 (85.0DEGC). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 3 HAD AN ADJUSTED TEMPERATURE OF +86.2C, 0.2C HIGHER THAN THE ACCEPTABLE RANGE PER 03838. DUE THE FINDING, RISK ASSESSMENT QUESTION 2 WAS UPDATED TO 'YES'. THE CUSTOMER SITE IS CURRENTLY RUNNING THE RP FLEX VERIGENE ASSAY. THE AMP HEATER VE

  Patient problems: Insufficient Information

  MAUDE report 14273431 ↗