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

Catalog Number	08105383190
Medical Device Problem Codes	Low Test Results (2458); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable amik gen.2 (amikacin) result from cobas pro c 503 analytical unit serial number (b)(6).The initial result was 69.8 g/ml with a data flag.The repeat result with an analyzer dilution was 71.4 g/ml with a data flag.The customer performed a manual 1:2 dilution and the result was 29.8 g/ml.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not find a product issue.The manual dilution factor has to be applied manually.
Additional Manufacturer Narrative
Medwatch fields a2 and a3 have been updated.It was confirmed that the value of 29.8 g/ml is the result of a manual dilution 1:1.Per product labeling: "manually dilute samples above the measuring range 1 + 1 with the preciset tdm ii diluent (0 g/ml) and reassay.Multiply the result by 2 to obtain the specimen value." the correct value is therefore 59.6 g/ml.

• 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: 16994469
• Report Number: 1823260-2023-01734
• Device Sequence Number: 20579065
• Product Code: KLP
• UDI-Device Identifier: 07613336133514
• UDI-Public: 07613336133514
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 07/17/2023

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: 1234
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 07/06/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/16/2023; 07/17/2023
• 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 Age: 51 YR
• Patient Sex: Female