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

Model Number	07P9930
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6) (different samples for the same patient).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely decreased alinity c creatinine result for a patient that the physician was questioning after receiving the result.The following data was provided (customer¿s normal range for creatinine: 0 -1.3 mg/dl).On (b)(6) 2023 sid: (b)(6): creatinine result: 0.5 mg/dl.On (b)(6) 2023 sid: (b)(6): creatinine result: 3.039 / sid: (b)(6): creatinine result: 4.38 mg/dl.I-stat creatinine result: 6.2 there was no impact to patient management reported.
Event or Problem Description
The customer reported a falsely decreased alinity c creatinine result for a patient that the physician was questioning after receiving the result.The following data was provided (customer¿s normal range for creatinine: 0 -1.3 mg/dl).On (b)(6) 2023 sid (b)(6): creatinine result: 0.5 mg/dl on (b)(6) 2023 sid (b)(6): creatinine result: 3.039 / sid (b)(6): creatinine result: 4.38 mg/dl i-stat creatinine result: 6.2 there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased alinity c creatinine results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.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.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.

• 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: 16421956
• Report Number: 3002809144-2023-00093
• Device Sequence Number: 5341442
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/01/2023

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: 02/13/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/01/2023
• 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, (B)(6).; ALNTY C PROCESSING MODU, 03R67-01, (B)(6).
• Patient Sex: Unknown