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	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated alinity c creatinine result generated for a female patient sample.The following data was provided: sample id (b)(6) initial result = 23.34 mg/dl, repeat = 0.94 mg/dl, 0.95 mg/dl, 0.95 mg/dl, 0.97 mg/dl, repeat results on another analyzer (b)(6) = 0.88 mg/dl and 0.86 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry : (b)(6).All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Update: section d4 - expiration date updated from blank to 9/14/2023, and h4 - device mfg date updated from blank to 6/16/2022.The complaint investigation for falsely elevated alinity c creatinine results included a search for similar complaints, review of complaint text, ticket trending review, labeling review, device history record review, and field data review.Return testing was not performed as returns were not available.The complaint activity is normal for reagent lot 60912un22.A review of tracking and trending did not identify any related trends for the product for the issue.A review of the device history records did not identify any non-conformances or deviations associated with the lot number 60912un22 and complaint issue.The overall performance of alinity c creatinine reagents was reviewed using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 60912un22.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for alinity c creatinine reagent lot 60912un22.
Event or Problem Description
The customer observed a falsely elevated alinity c creatinine result generated for a female patient sample.The following data was provided: sample id (b)(6) initial result = 23.34 mg/dl, repeat = 0.94 mg/dl, 0.95 mg/dl, 0.95 mg/dl, 0.97 mg/dl, repeat results on another analyzer ((b)(6)) = 0.88 mg/dl and 0.86 mg/dl no impact to patient management was reported.

• 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: 17051211
• Report Number: 3002809144-2023-00258
• Device Sequence Number: 17008093
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2023

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: 09/14/2023
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 60912UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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, AC05063; ALNTY C PROCESSING MODU, 03R67-01, AC05063
• Patient Age: 66 YR
• Patient Sex: Female