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	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that a falsely elevated alinity c creatinine result of 539 umol/l was generated for a patient sample (id (b)(6)) on (b)(6) 2021.The patient was admitted to the hospital for suspected acute kidney injury (aki) approximately 2 hours later based on the result.A new sample was drawn (id (b)(6)) and the result was 78 umol/l.The first sample was then retested and the result was 83 umol/l.There is no report of any incorrect/unnecessary treatment given to the patient or any patient injury based on the falsely elevated result.
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
Quality control (qc) was within range on the instrument on the day of the initial measurement, indicating the assay was performing as expected.The logs were reviewed, and the reaction graph was abnormal for the initial test compared with other results of similar values.The investigation determined there is normal complaint activity for lot number 45043un21.The trend review by the product list number found no adverse or non-statistical trends related to this issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Review of the capa database found no issue related to the current complaint.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no deficiency for lot number 45043un21 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12863984
• Report Number: 3002809144-2021-00672
• Device Sequence Number: 4571019
• 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): 12/07/2021

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: 10/22/2022
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 45043UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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, (B)(6). ; ALNTY C PROCESSING MODU, 03R67-01,(B)(6).
• Patient Sex: Unknown