MAUDE Adverse Event Report: ABBOTT GMBH CREATININE; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	3L81-23
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and field data review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify an increase in complaint activity for the complaint lot and no trends were identified.The overall performance of the complaint lot in the field was reviewed using data gathered from customers worldwide.The patient median result for the complaint lot number 06557un20 is within established control limits indicating the assay was performing as expected.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and sufficiently addresses the customer¿s issue.No systemic issue or deficiency of creatinine reagent lot number 06557un20 was identified.
Event or Problem Description
The customer observed falsely elevated creatinine results generated on the architect c8000 processing module for one patient.The following data was provided (reference range: 53 to 100 umol/l): (b)(6) 2021 sid (b)(6) initial result = 263.8 umol/l, repeat = 263.8 umol/l, repeat on another architect = 264.1 umol/l, roche = 112.6 umol/l, no impact to patient management was reported.

• Brand Name: CREATININE
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12195815
• Report Number: 3002809144-2021-00438
• Device Sequence Number: 3397854
• Product Code: CGX
• UDI-Device Identifier: 00380740161552
• UDI-Public: 00380740161552
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K083809
• 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
• Report Date (Section B): 07/20/2021

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 Expiration Date: 02/27/2022
• Device Model Number: 3L81-23
• Device Catalogue Number: 03L81-23
• Device Lot Number: 06557UN20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1