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

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.

• Brand Name: NH3L AMMONIA
• Type of Device: 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: 6061132
• MDR Text Key: 58545579
• Report Number: 1823260-2016-01649
• Device Sequence Number: 1
• Product Code: JIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• 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 Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 20766682322
• Device Lot Number: 15816001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2016
• 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: N
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CARVEDILOL; FUROSEMIDE; METFORMIN; PENTOPRAZOL; SPIRONOLACTONE; TREZEDOME
• Patient Age: 69 YR
• Patient Weight: 66