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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS NH3L AMMONIA ENZYMATIC METHOD, AMMONIA Back to Search Results
Catalog Number 20766682322
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2017
Event Type  Malfunction  
Manufacturer Narrative

The investigation is ongoing. This event occurred in (b)(6).

 
Event Description

The initial reporter received questionable nh3l ammonia results for three patients from cobas 8000 cobas c 702 module serial number (b)(4). The customer suspected an interference. Data was only provided for two of the patients. Patient 1: the specific date of this event was not known, therefore (b)(6) 2017 was used. In (b)(6) 2017, the child patient had liver failure and received a liver transplant. After surgery she had tpn (total parenteral nutrition) with smof (lipids) and numeta (a. O. Amino acids/trace elements, but not additional lipids). With the nh3l assay, high ammonia concentrations were reported, around 120 mol/l over several days. Dialysis (cvvh) was started because of kidney failure, but ammonia levels did not decrease. Six days post liver transplant the patient's the initial ammonia result 173 umol/l. The laboratory technician made a 1:1 dilution and the result was 90 umol/l. He suspected a collection error, requested a new sample, and observed exactly the same. No specific data was provided for the new sample. For a new sample on (b)(6) 2019, the initial result was 73. 2 umol/l and was reported outside of the laboratory. The same sample was repeated later that day and the result was 58. 0 umol/l. The same sample was repeated using nh3l ammonia gen 2 reagent and the result was 15. 5 umol/l. Patient 2: on (b)(6) 2019, the nh3l result was 130. 6 umol/l, but nh3l gen 2 result was 21. 4 umol/l. A 1:2 dilution was performed and the result was 27. 5 umol/l. On (b)(6) 2019, the nh3l result was 130. 6 umol/l, but nh3l gen 2 result was 21. 3 umol/l. A 1:2 dilution was performed and the result was 55 umol/l. The questionable results were reported outside of the laboratory.

 
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Brand NameNH3L AMMONIA
Type of DeviceENZYMATIC 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 Key9353289
MDR Text Key219406645
Report Number1823260-2019-04150
Device Sequence Number1
Product Code JIF
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK972250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number20766682322
Device LOT NumberASKU
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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