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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.Patient information: no further information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained a falsely elevated alinity c creatinine result.Sample id (b)(6) generated an initial result of 660.87 umol/l and retest of 82.30 umol/l.Due to the elevated result the patient went to the a&e and had blood tests.No further impact was reported.Due to the elevated result the patient went to the a&e and had blood tests.No adverse impact was reported.
Event or Problem Description
The customer obtained a falsely elevated alinity c creatinine result.Sample id(b)(6) generated an initial result of 660.87 umol/l and retest of 82.30 umol/l.Due to the elevated result the patient went to the a&e and had blood tests.No further impact was reported.Due to the elevated result the patient went to the a&e and had blood tests.No further impact was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for reagent lot 09740un20.Trending review identified no trends for elevated results for the alinity c creatinine assay.Device history record review did not identify any non-conformances or deviations related to the complaint issue.Return testing was not completed as returns were not available.The issue appears to be sample specific for certain patient samples.The sample was repeated twice on two different analyzers and an acceptable result was generated.Quality control results were within range at the time of the incident.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of alinity c creatinine, lot 09740un20 was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• 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: 11666939
• Report Number: 3002809144-2021-00253
• Device Sequence Number: 11543700
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• 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): 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): 05/24/2021

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: 03/25/2022
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 09740UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/24/2021
• 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, AC02032; ALNTY C PROCESSING MODU, 03R67-01, AC02032