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

Catalog Number 04490789190

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable benz benzodiazepines plus results on one sample from one patient on cobas 6000 c (501) module analyzer, serial number (b)(4).The patient was pregnant, in the third trimester, and in opioid withdrawal during delivery.On (b)(6) 2017, the patient received three injections of lorazepam 2mg at 2:15 am, 7:45 am, and 8:51 am.At an unspecified time on (b)(6) 2017, the patient's urine result was negative for benz benzodiazepines plus and was reported outside the laboratory.The customer used a value of 100 ng/ml for the cutoff point for the assay.The customer states that there was some blood present in the patient's urine sample.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 gas chromatography/mass spectrometry (gc/ms) and the result was 250 ng/ml (positive) for lorazepam.The result by gc/ms was believed to be correct.On (b)(6) 2017, the customer repeated the same sample on the c501 module, and the result was again negative.On (b)(6) 2017, the customer repeated the same sample on a second c501 module, and the result was again negative.The patient was not adversely affected.Review of the available calibration and qc information found the results were within the permissible range.The calibrations performed on (b)(6) 2017 and (b)(6) 2017 showed that they were consistent, but at a lower absorbance than previous calibrations with this reagent lot.The customer refused a service visit to check the analyzer.

Manufacturer Narrative

A specific root cause could not be identified.Calibration and quality controls were acceptable.There was no indication of a general issue with the system or the reagent.Lorazepam is generally present in the urine as the glucuronide, thus lorazepam cannot be detected if the sample is not pre-treated with glucuronidase before testing.The cross-reactivity to lorazepam glucuronide is about 0.5% as stated in the instructions for use.The benzodiazepines plus reagent does not contain glucuronidase.For gc-ms the samples are generally pre-treated with glucuronidase.

• Brand Name: BENZ BENZODIAZEPINES PLUS
• 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: 6368893
• MDR Text Key: 68767956
• Report Number: 1823260-2017-00439
• Device Sequence Number: 1
• Product Code: JXM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043327
• 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: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 04490789190
• Device Lot Number: 16728801
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• 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
• Patient Age: 46 YR
• Patient Weight: 62