MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BENZ BENZODIAZEPINES; ENZYME IMMUNOASSAY, BENZODIAZEPINE

Catalog Number 20737984122

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable benz benzodiazepines results for one patient from cobas integra 400 plus serial number (b)(4).The urine result was negative and was reported outside the laboratory.The customer used a value of 200 for the cutoff point for the assay.As the patient was on lorazepam and the result was expected to be positive, the physician asked for confirmation testing.The customer sent the sample for confirmation testing by gc/ms and the result was 1074 ng/ml (positive).The result by gc/ms was believed to be correct.On (b)(6) 2016, the customer repeated the same sample on the cobas integra 400 plus and the result was again negative.The patient was not adversely affected.The customer refused a service visit to check the analyzer.

Manufacturer Narrative

Based on the information provided, a specific root cause could not be determined.As the sample in question was not available, further investigation was not possible.Additional information for further investigation was requested but was not provided.It was suspected a substance in the sample was interfering with the assay.Calibration and qc data were acceptable and did not indicate any reagent issue and confirmed the assay was performing within specifications.

• Brand Name: BENZ BENZODIAZEPINES
• Type of Device: ENZYME IMMUNOASSAY, BENZODIAZEPINE
• 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: 6188420
• MDR Text Key: 62803103
• Report Number: 1823260-2016-02018
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20737984122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• 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: LORAZEPAM