MAUDE Adverse Event Report: ABBOTT GMBH CREATININE; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	3L81-33
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 elevated creatinine result on one patient sample when running on the architect c16000 processing module.The following data was provided: initial creatinine result = 7.61 mg/dl; repeat on another analyzer = 0.78 mg/dl; repeat on the first analyzer = 0.75 mg/dl there was no impact to patient management reported.
Event or Problem Description
The customer reported a falsely elevated creatinine result on one patient sample when running on the architect c16000 processing module.The following data was provided: initial creatinine result = 7.61 mg/dl; repeat on another analyzer = 0.78 mg/dl; repeat on the first analyzer = 0.75 mg/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
Customer returns were not available.Trending review determined no trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Historical performance of reagent lot 09280un22 was evaluated using world-wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 09280un22 is within the established control limits.Based on the investigation, no deficiency for lot number 09280un22 was identified.

• Brand Name: CREATININE
• 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: 16890854
• Report Number: 3002809144-2023-00226
• Device Sequence Number: 20411213
• Product Code: CGX
• UDI-Device Identifier: 00380740161569
• UDI-Public: 00380740161569
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 06/29/2023

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: 07/12/2023
• Device Model Number: 3L81-33
• Device Catalogue Number: 03L81-33
• Device Lot Number: 09280UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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: ARC C16K PRC MOD, 03L77-01, C1601213; ARC C16K PRC MOD, 03L77-01, C1601213
• Patient Sex: Unknown