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	04/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).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 increased creatinine result generated on the architect c16000 analyzer on a patient.Results provided: on (b)(6) 2022 sid (b)(4) (normal range: 0.6-1.3 mg/dl).Serum sample: sn# (b)(4) = 2.8 mg/dl, sn# (b)(4) = 2.8 mg/dl.Previous result for this patient = 0.9 mg/dl, (b)(6) labs (roche platform) = 0.9 mg/dl plasma sample drawn at same time = 0.9 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data analysis.Return testing was no completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any trends.Device history review did not identify any nonconformances or deviations associated with the complaint list number.A review of the creatinine population result median by reagent lot chart shows field data results within expected ranges.Labeling was reviewed and adequately addresses the issue.Use error may have contributed to the customer¿s issue as the pre-analytical serum sample preparation must use the tube manufacturer's processing steps and the sample presented to the analyzer must meet the instructions for use conditions.Based on the investigation, no systemic issue or product deficiency was identified for creatinine reagent lot 02564un21.

• 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: 14360445
• Report Number: 3002809144-2022-00170
• Device Sequence Number: 4865889
• Product Code: CGX
• UDI-Device Identifier: 00380740161569
• UDI-Public: 00380740161569
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/13/2022

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: 11/17/2022
• Device Model Number: 3L81-33
• Device Catalogue Number: 03L81-33
• Device Lot Number: 02564UN21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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: ARC C16K PRC MOD, 03L77-01, C1601485.; ARC C16K PRC MOD, 03L77-01, C1601485.
• Patient Sex: Unknown