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	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that a (b)(6) alinity c creatinine result of (b)(6) was generated for a patient sample ((b)(6)) on (b)(6), 2022 that retested at (b)(6).An additional occurrence occurred on (b)(6), 2022.Sid (b)(6) initial result was (b)(6) and repeat result was (b)(6).No adverse impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity c creatinine results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history review, and labeling review.Return testing was not completed as returns were not available.A review of tickets determined there is normal complaint activity for lot number 47269un21.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 47269un21 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.The sample when repeated generated lower normal results.A sample related issue could not be ruled out.Based on our investigation, no systemic issue or deficiency with alinity c creatinine reagent lot 47269un21 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14114113
• Report Number: 3002809144-2022-00131
• Device Sequence Number: 5289586
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 05/10/2022

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: 05/04/2023
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 47269UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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, AC02891; ALNTY C PROCESSING MODU, 03R67-01, AC02891
• Patient Sex: Unknown