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 2018-01-09 for BENZ BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[96837138]
Unique identifier (udi)# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96837139]
The customer complained of a false negative result for 1 patient sample tested for benz benzodiazepines plus (benz) on a cobas 6000 c (501) module which was later confirmed positive by the reference method. The sample was initially tested for benz at another laboratory, site a, on a cobas c501 on (b)(6) 2017 and a negative result was obtained, specific result not provided. This result was questioned by the physician based on the patient being prescribed clonazepam. The sample was sent to the laboratory, site b, for confirmation testing. Liquid chromatography? Mass spectrometry (lc/ms) testing for 7-aminoclonazepam was performed on (b)(6) 2017 and a result of 1451. 166 ng/ml was obtained. This is a confirmed positive result and this result was deemed to be correct. The customer tested for benz on (b)(6) 2017 on their cobas c501, using a benz cutoff of 300, and a negative result was obtained (-93 mabs). The customer stated that they have not had any recent issues with the analyzer or with any qc or other patient results. It was noted that the sample in question was stored refrigerated for greater than the recommended 5 days recommended per product labeling. Site a? S cobas c501 serial number was (b)(4). The benz reagent lot that was used at site a was 20897601 with an expiration date of 31-oct-2018. A field engineering specialist visited site site a and performed a precision check. He did not mention finding any problems and stated the patient sample was probably the cause of the inaccuracy. Site b? S cobas c501 serial number was (b)(4). Lot information as well as initial reporter correspond to site b. Site b refused a service visit as they felt the issue was sample related. It was noted that site b was using expired lots of calibrators and controls. There were no adverse events. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
[131701202]
Retention testing of benz reagent lots 250726 and 208976 was performed. 7-aminoclonazepam recovery was acceptable a general reagent issue can be excluded. For the patient sample in question, it is believed an unknown interference might have caused the false negative result despite the presence of 7-aminoclonazepam. A possible root cause could be related to how the sample was collected, for example the use of a catheter for collection or addition of disinfectants or cleaning agents in the sample.
Patient Sequence No: 1, Text Type: N, H10
[131704139]
Upon further investigation it was determined that the initial negative benz results are confirmed correct. Using high-performance liquid chromatography-electrospray ionisation tandem mass spectrometry (hplc-esi-ms) testing method, no 7-aminoclonazepam could be found in the patient sample. Neither could metabolites nor degradation substances be detected in the patient sample from the customer. A root cause for the high lc-ms result from the customer site could not be explained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00090 |
| MDR Report Key | 7176325 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-09 |
| Date of Report | 2018-04-17 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2017-12-18 |
| Date Added to Maude | 2018-01-09 |
| 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 | 2018-01-09 |
| 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 | 2018-01-09 |