MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-01 for COBAS TAQMAN HBV (HIGH PURE) TEST, US-IVD 03577163190 manufactured by Roche Molecular Systems.
[1300242]
A customer site in (b)(6) reported that a false "target not detected" result was generated with a patient sample when tested with the cobas taqman hbv test for use with the high pure system, us-ivd (hps ctm hbv). The customer site indicated the discrepancy was identified when the patient sample was tested with an in-house qualitative test (same sample collection) and upon repeat testing with the hps ctm hbv test, us-ivd (new sample collection). The customer specified that the original "target not detected" result, which was generated on (b)(6) 2009, was the first time this patient was tested with the hps ctm hbv test, us-ivd. Although requested, the impact to patient treatment, if any, was not available.
Patient Sequence No: 1, Text Type: D, B5
[8539056]
Quality control release testing data were reviewed and a complaint history analysis was performed. The complaint kit lot, m03237, was previously tested, on (b)(4) 2010, as part of an (b)(4) study and all results met specification. Additionally, the complaint kit met all quality control release testing specifications upon release; no failure or out of specification result was generated. Upon reviewing the complaint history for the complaint kit lot, a previous case (filed by the same customer) was detected. It appears that the same issue occurred for a different patient sample (i. E. , initial collection tnd; recollection (b)(6)). For the previous complaint case the growth curves were available and the tnd result generated was determined to be due the baseline of the normalized target curve. Unfortunately, for this current complaint case, we cannot assess the growth curves for the initial testing (tnd result) as no raw data was provided. Additionally, the customer site was unable to provide the patient specimen from the initial test run. Therefore, we cannot determine whether the current complaint case is related to the baseline normalization of the target curve or a sample specific issue with the original sample collection. Based on the information available, a device failure/malfunction could not be detected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00012 |
| MDR Report Key | 1648223 |
| Report Source | 05 |
| Date Received | 2010-04-01 |
| Date of Report | 2010-03-05 |
| Date of Event | 2009-12-02 |
| Date Mfgr Received | 2010-03-05 |
| Device Manufacturer Date | 2009-06-19 |
| Date Added to Maude | 2011-04-21 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQMAN HBV (HIGH PURE) TEST, US-IVD |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2010-04-01 |
| Catalog Number | 03577163190 |
| Lot Number | M03237 |
| Device Expiration Date | 2010-05-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-01 |