MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-12-08 for COBAS? AMPLIPREP/COBAS? TAQMAN? HBV TEST, V2.0 CE-IVD 04894570190 manufactured by Roche Molecular Systems.
[15848521]
(b)(4) -performance tests performed. (b)(4) - configuration issue. (b)(4) - device incorrectly prepared for use or modified. Additional information; device evaluation. Urgent medical device correction additional information provided. Roche molecular diagnostics has confirmed an issue regarding liquid level detection of the cs1 magnetic glass particles (mgp) reagent cassette of the cobas ampliprep/cobas taqman (cap/ctm) hbv v2. 0 test on the cobas ampliprep instrument. The test definition files (tdf) for cap/ctm hbv v2. 0 do not have level detection activated for the cs1 (mgp) reagent cassette. In the event that a cs1 reagent cassette is misassembled and no mgp reagent is present, it would not be detected when using the cap/ctm hbv v2. 0 test. The load check would not recognize the missing reagent and the run would continue, with the possibility of producing erroneous but believable results. The following assays are affected: cobas ampliprep-cobas taqman hbv v 2. 0 us-ivd, m/n (b)(4). Cobas ampliprep - cobas taqman hbv v 2. 0 ce-ivd, m/n (b)(4). The misassembled reagent cassette is believed to be a single occurrence, caused by human error. (b)(4). The test definition files for the cap/ctm hbv v2. 0 test will be updated with liquid level detection for the cs1 reagent cassette activated. This corrective action will prevent the issue from recurring. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20746817]
A customer from (b)(6) filed a complaint alleging that the mgp (magnetic glass particle) reagent bottle was misplaced within cassette 1 (cs1) of a kit cap-g/ctm hbv v2. 0 72tests ce-ivd (m/n 04894570190; lot n05553). Unflagged results were generated with this cassette and no error messages were generated even though the cobas ampliprep instrument was not pipetting any mgp reagent.
Patient Sequence No: 1, Text Type: D, B5
[20814489]
The issue is under investigation. No conclusions can be drawn at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00045 |
| MDR Report Key | 1917263 |
| Report Source | 01,05 |
| Date Received | 2010-12-08 |
| Date of Report | 2010-11-09 |
| Date of Event | 2010-11-07 |
| Date Mfgr Received | 2010-11-09 |
| Date Added to Maude | 2012-01-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202 |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Street | 1080 US HWY 202 |
| Manufacturer City | BRANCHBURG NJ 08876373 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 3733 |
| Single Use | 0 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS? AMPLIPREP/COBAS? TAQMAN? HBV TEST, V2.0 CE-IVD |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2010-12-08 |
| Catalog Number | 04894570190 |
| Lot Number | N05553 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-08 |