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

Model Number	07P9930
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = (b)(6).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 alinity c creatinine results on one patient.The results provided were: on (b)(6) 2021 (b)(6) initial = 9.35mg/dl (normal range 0.72-1.25mg/dl) / retest after 30 minutes = 0.73mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot number 02995un20.Trending review determined no trends for elevated patient results due to the product.Return testing was not completed as returns were not available.File sample analysis was not performed as retesting of the sample gave expected normal results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of alinity creatinine reagent, lot number 02995un20 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: 11250469
• Report Number: 3002809144-2021-00068
• Device Sequence Number: 17019710
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (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): 02/08/2021

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: 01/10/2022
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 02995UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/08/2021
• 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, AC02027; ALNTY C PROCESSING MODU, 03R67-01, AC02027; ALNTY C PROCESSING MODU, 03R67-01, (B)(4)
• Patient Age: 41 YR