MAUDE Adverse Event Report: ROCHE DIAGNOSTICS NH3L AMMONIA; ENZYMATIC METHOD, AMMONIA

Catalog Number	07236450190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration and qc were acceptable.Abnormal aspiration and sample short alarms were observed on the alarm trace data.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable nh3l ammonia results for two patients whose samples were tested on a cobas 8000 c702 module with serial number (b)(4).The initial results were not reported outside of the laboratory.The reporter reran the samples on decreased mode.The samples were also manually diluted.For patient 1, the reporter calculated the average of the 1:2 and 1:3 dilutions and reported it as the final result of the initial sample.New samples were also obtained from the patient.On (b)(6) 2021 at 6:57, patient 1 had an initial result of -200.2 umol/l with a data flag.The repeat result was -138.7 umol/l with a data flag.The repeat result at 7:38 was -200.2 umol/l with a data flag.The repeat result at 7:56 was 110.9 umol/l.The decreased mode result was 180.1 umol/l.The repeat result at 8:30 at 1:5 dilution was 110 umol/l.The repeat result at 8:31 at 1:2 dilution was 126.4 umol/l.The repeat result at 8:31 at 1:3 dilution was 131.7 umol/l.The repeat result at 8:32 at 1:4 dilution was 120.4 umol/l.The repeat result at 8:32 at 1:10 dilution was 179 umol/l.The repeat result at 9:53 using an undiluted sample was -22.9 umol/l with a data flag.On (b)(6) 2021, the new sample from patient 1 had an initial result at 6:25 of -258.2 umol/l with a data flag.The repeat result at 6:38 was -239.1 umol/l with a data flag.The repeat result at 7:07 on decreased mode was 101.7 umol/l.The repeat result at 6:58 at 1:3 dilution was 265.8 umol/l.The repeat result at 7:47 at 1:3 dilution was 139.5 umol/l.The repeat result at 7:46 at 1:2 dilution was 129.2 umol/l.On (b)(6) 2021 at 6:21, the new sample from patient 1 had an initial result of 572.9 umol/l with a data flag.The decreased mode result at 6:37 was 67.0 umol/l.The repeat result at 6:37 at 1:2 dilution was 60.8 umol/l.The repeat result at 6:38 1:3 dilution was 56.1 umol/l.On (b)(6) 2022, patient 2 had an initial result of -285.7 umol/l with a data flag.The repeat result using decreased mode was 26.4 umol/l.The repeat result at 5:52 at 1:2 dilution was 27.4 umol/l.The repeat result at 5:52 at 1:2 dilution was 20.2 umol/l.
Additional Manufacturer Narrative
A general reagent problem can be excluded because the provided qc and calibration data were within specifications.The reaction kinetics and additional results from the patient indicate serious liver problems.It was concluded that there was an issue with the patient's sample affecting the nh3l results.The investigation determined that the event was consistent with an issue in the patient's plasma sample.The investigation did not identify a product problem.

• Brand Name: NH3L AMMONIA
• Common Device Name: ENZYMATIC METHOD, AMMONIA
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13319614
• Report Number: 1823260-2022-00180
• Device Sequence Number: 1646594
• Product Code: JIF
• UDI-Device Identifier: 04015630936533
• UDI-Public: 04015630936533
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K972250
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 01/31/2023
• Device Catalogue Number: 07236450190
• Device Lot Number: 57484001
• 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: 12/29/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 02/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE THE ATTACHMENT IN THE MEDWATCH.
• Patient Sex: Male