• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS NH3L AMMONIA ENZYMATIC METHOD, AMMONIA Back to Search Results
Model Number C501
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2018
Event Type  Malfunction  
Manufacturer Narrative

This event occurred in (b)(6). (b)(4).

 
Event Description

The customer stated that they received questionably high results for an unspecified number of patient samples tested for nh3l ammonia (nh3) on a cobas 6000 c (501) module - c501. Samples will repeat in normal ranges. The customer provided data for one patient sample which had an erroneous nh3 result that was reported outside of the laboratory. The sample initially resulted as 193. 5 ug/l. The value was reported outside of the laboratory to the doctor, who asked for a rerun of the sample since the value was not compatible with the patient's clinical history. The sample was repeated on the same analyzer, resulting as 33. 1 ug/dl. The sample was also repeated on a second c501 analyzer, resulting as 30. 6 ug/l. No adverse events were alleged to have occurred with the patient. The nh3 reagent lot number was 273314, with an expiration date of 31-mar-2019. The last calibration performed on (b)(6) 2018 was flagged with an error. Quality control recovery was not stable, but was within range on the date of the event. Several abnormal probe aspiration alarms occurred on (b)(6) 2018.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7337229
MDR Text Key103010519
Report Number1823260-2018-00823
Device Sequence Number1
Product Code JIF
Combination Product (Y/N)N
Reporter Country CodeGR
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
Report Date 03/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL NumberC501
Device Catalogue Number20766682322
Device LOT Number273314
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 Received02/28/2018
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

-
-