MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE REAGENT KIT; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	07P9920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
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.
Event or Problem Description
The customer reported falsely elevated creatinine result on one patient generated on the alinity c processing module.The results provided were: on (b)(6) 2021 sid (b)(6) initial = 375.6umol/l (normal range for female 50-98umoll) / retested = 64umol/l / the sample was then tested on all 3 analyzers with results 66, 67, 71umol/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 37972un21.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any issues associated with lot 37972un21 and the complaint issue.The issue appears to be sample specific for certain patient samples caused by pre-analytic issues.As part of troubleshooting the issue was retested on multiple analyzers and acceptable results were generated.The lot review also suggests the product is performing acceptably and performing as expected.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of creatinine (ln 07p99-20) lot 37972un21 was identified.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12253982
• Report Number: 3002809144-2021-00458
• Device Sequence Number: 4599914
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 07/14/2022
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 37972UN21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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, AC03757; ALNTY C PROCESSING MODU, 03R67-01, AC03757