MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA BENZODIAZEPINES; ENZYME IMMUNOASSAY, BENZODIAZIPINE

Catalog Number 20737984122

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable false negative benzodiazepines results for two samples from one patient from the integra 800 analyzer serial number (b)(4).The customer used a cut off value of 200.The first sample from the patient was tested on (b)(6) 2015 and reported as 73 (negative).The physician requested another sample on (b)(6) 2015 and the result was 177 (negative).The physician questioned the results and asked that the customer send samples from the patient out for confirmation.The results by gc/ms were positive.Refer to the attachment to the medwatch for the specific results.All of the results were reported outside the laboratory.The patient was not adversely affected.It was noted the calibration performed prior to the first questionable result was performed using expired calibrator material.

Manufacturer Narrative

A specific root cause could not be identified.An unknown interference was suspected to be in the sample.

• Brand Name: COBAS INTEGRA BENZODIAZEPINES
• Type of Device: ENZYME IMMUNOASSAY, BENZODIAZIPINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5135002
• MDR Text Key: 27818284
• Report Number: 1823260-2015-04294
• Device Sequence Number: 1
• Product Code: JXM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 20737984122
• Device Lot Number: 60194801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 09/23/2015
• 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