MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-01 for BENZ BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[68767956]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68767957]
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.
Patient Sequence No: 1, Text Type: D, B5
[69779168]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00439 |
| MDR Report Key | 6368893 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-13 |
| Date of Event | 2017-01-28 |
| Date Mfgr Received | 2017-02-09 |
| Date Added to Maude | 2017-03-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENZ BENZODIAZEPINES PLUS |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZEPINE |
| Product Code | JXM |
| Date Received | 2017-03-01 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 16728801 |
| ID Number | NA |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |