MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C GLUCOSE REAGENT KIT; HEXOKINASE, GLUCOSE

Model Number	07P5520
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer due to privacy issues.
Event or Problem Description
The customer reported falsely elevated glucose results on one patient generated on the alinity c processing module.The results provided were: initial = 13mmol/l (234.23mg/dl) / retested = 12mmol/l (216.22mg/dl); the next day, same patient, new draw at (b)(6) = about 5 mmol/l (90.09mg/dl).There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets was performed for reagent lot number 58044uq09.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending by list number did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity c glucose reagent ln 7p55-20/lot number 58044uq09 was identified.

• Brand Name: ALINITY C GLUCOSE REAGENT KIT
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12211544
• Report Number: 3002809144-2021-00442
• Device Sequence Number: 11868413
• Product Code: CFR
• UDI-Device Identifier: 00380740135447
• UDI-Public: 00380740135447
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K170316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 07P5520
• Device Catalogue Number: 07P55-20
• Device Lot Number: 58044UQ09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C PROCESSING MODU, 03R67-01, AC03608.; ALNTY C PROCESSING MODU, 03R67-01, AC03608.; ALNTY C PROCESSING MODU, (B)(4)