MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AMIKACIN; AMIKACIN SERUM ASSAY

Catalog Number	08105383190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : na.
Event or Problem Description
The initial reporter received questionable amikacin results from two patient samples tested on the cobas pure c 303 analytical unit with serial number (b)(4).The reporter complained that the results between the cobas pure and the cobas integra were different.The initial results were reported outside of the laboratory.Patient 1 on (b)(6) 2023, the initial result from the cobas integra was 2.3 ug/ml.On (b)(6) 2023, the repeat result from the cobas pure was 5.2 ug/ml.Patient 2 on (b)(6) 2023, the initial result from the cobas integra was 2.0 ug/ml.On (b)(6) 2023, the repeat result from the cobas pure was 5.0 ug/ml.
Additional Manufacturer Narrative
The investigation determined that the sample results are not directly comparable as they come from different blood collections but noted that the concentration should decrease since there was no medication given inbetween tests.Based on the information provided, the cause of the event could not be determined.

• Brand Name: AMIKACIN
• Common Device Name: AMIKACIN SERUM ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16712200
• Report Number: 1823260-2023-01134
• Device Sequence Number: 16569123
• Product Code: KLP
• UDI-Device Identifier: 07613336133514
• UDI-Public: 07613336133514
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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 Catalogue Number: 08105383190
• Device Lot Number: 631861
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown