MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-10-06 for BENZ BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[89937848]
(b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[89937849]
The customer complained of a false positive benz benzodiazepines plus (benz) result. The initial benz result run on a cobas 8000 c 502 module (c502) was positive (321 ng/ml). The clinician questioned the result because if confirmed the patient would be moved from a low secure to a high secure setting. The repeat result from the same analyzer was again positive (328 ng/ml). Repeat testing was performed on (b)(6)2017. The sample was sent away for confirmation testing using gas chromatography? Mass spectrometry (gc/ms) and a negative result was obtained. The negative result obtained from the gc/ms testing was believed to be correct as all previous and subsequent results for the patient have been negative for benz. The initial result was reported outside of the laboratory. There was no allegation of an adverse event. The c502 serial number was (b)(4). Since the patient had taken a dose of olanzapine prior to the sample collection a potential cross reactivity was questioned by the customer. A cross reactivity of benz with olanzapine can be excluded as the root cause. Investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02210 |
| MDR Report Key | 6921529 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-06 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2017-09-18 |
| Date Added to Maude | 2017-10-06 |
| 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 | 2017-10-06 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2017-10-06 |