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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 Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer stated that they received erroneous results for five samples from the same patient tested for nh3l ammonia (nh3) on a c501 analyzer. The results from all 5 samples were reported outside of the laboratory and sent back by the doctor due to not matching the patient's clinical condition. (b)(6). The patient was not adversely affected. The c501 analyzer serial number was (b)(4). When the customer was asked about reagent handling, it was confirmed that the customer did not unscrew a reagent bottle cap and leave the reagent cassette in a dark, covered place for 24 hours prior to placing it on the instrument as instructed in the package insert. The customer was informed that not doing this would result in high ammonia recovery. The customer was informed that the current reagent pack should not be used and that a new reagent cassette should be prepared for use according to the package insert. The customer prepared a new cassette as instructed. Calibration and controls were acceptable with the new cassette. Controls had a slight decrease in recovery for the new cassette versus control recovery for the old cassette that had not been prepared properly. The field service engineer could not determine a cause. He checked probe adjustments, wash pressures, the rinse mechanism, and dry positions. Everything was found to be ok. The customer ran calibration and controls; the results were ok. The customer ran a precision study and this was ok.

 
Manufacturer Narrative

The field service engineer checked special wash programming and this was good. The customer has not experienced any further issues since correctly handling reagent cassettes. Investigations have determined that the issue was solved by correct handling of the reagent cassette. The product was found to meet specifications.

 
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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 Key6061132
MDR Text Key58545579
Report Number1823260-2016-01649
Device Sequence Number1
Product Code JIF
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK972250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2017
Device Catalogue Number20766682322
Device LOT Number15816001
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 Received10/13/2016
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

Patient TREATMENT DATA
Date Received: 10/27/2016 Patient Sequence Number: 1
Treatment
ASPIRIN; CARVEDILOL; FUROSEMIDE; METFORMIN; PENTOPRAZOL; SPIRONOLACTONE; TREZEDOME
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