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 2018-07-27 for BENZ BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[115675039]
Patient Sequence No: 1, Text Type: N, H10
[115675040]
The customer is having issues detecting clonazepam in a patient sample using 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. Previous patient samples have had similar issues. Using the 300 ng/ml cutoff, the customer got an initial benz result of [-] 34, negative. The customer reported out the negative result to the physician, but they informed the physician they were doing additional confirmation testing. The sample was sent to an outside laboratory and the sample was confirmed positive for clonazepam with a result of 1124 ng/ml. The patient sample was tested on the cobas c501 on (b)(6) 2018 using the 100 ng/ml cutoff and the results were positive. The specific results were 27 and 26 both results with a data flag. The customer deemed these positive results as correct. There was no adverse event. The cobas c501 serial (b)(4). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02332 |
| MDR Report Key | 7727794 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-27 |
| Date of Report | 2018-08-24 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-06-29 |
| Date Added to Maude | 2018-07-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-07-27 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 25072601 |
| 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 | 2018-07-27 |