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 2018-06-04 for BENZ BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[110175575]
Unique identifier (udi)#: (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[110175576]
The customer is having issues detecting the 7-aminocloaclonacepam metabolite on the benzodiazepines plus (benz) assay on a cobas 6000 c (501) module. The customer complained of a false negative result for 1 patient sample tested for benz. The benz result from the c501 module was [-] 63. The drug was not present. The negative result was reported outside of the laboratory where the doctor questioned it. The sample was sent to an external laboratory where the result from the gas chromatography (gc)/liquid chromatography mass spectrometry (lcms) method was 528 ng/ml. This method was developed by the external laboratory and a disclaimer accompanied the result. The result of 528 ng/ml was believed to be correct. No adverse event occurred. The patient is in stable condition and is taking medications as prescribed under care of home visiting nurse. The c501 module serial number was (b)(4). There were no calibration errors or alarms prior to or after the event. Qc results were acceptable. The field service engineer (fse) visited the customer site and did not identify any issues. The customer alleges that with the reactivity listed in product labeling, the 7-aminocloaclonacepam metabolite should have been detected by the assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01719 |
| MDR Report Key | 7566348 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-04 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2018-06-04 |
| 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 | 2018-06-04 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 25072601 |
| ID Number | NA |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-06-04 |