MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-10-10 for COBAS TAQSCREEN MPX TEST 04584244190 manufactured by Roche Molecular Systems.
[2350405]
A customer site in (b)(6), reported that a donor specimen generated a (b)(6) test result, for (b)(6) when tested with the cobas taqscreen mpx test. Specifically, the customer reported that the donor specimen was (b)(6) in a pool of 6, with the cobas taqscreen mpx test and serology (b)(6) ((b)(6) core) with an unknown test. The customer then performed a resolution pool of one and generated (b)(6) results. The customer also repeated the serology test twice and generated (b)(6) results both times.
Patient Sequence No: 1, Text Type: D, B5
[9305662]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of this investigation will be communicated through a follow-up report. Note: product code mkt was selected as no alternative / more applicable code is available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19117993]
The customer alleged generating a (b)(6) result for a pools of 6 plasma sample tested with the cobas s201 taqscreen multiplex (mpx) assay when compared to results obtained from individual sample analysis using the mpx assay as well as (b)(6) serology testing of all samples in the pool. The customer's data shows a (b)(6) mpx pools of 6 result when using the taqscreen mpx assay. However, one of the six samples in the pools of 6 had a (b)(6) serology result when tested for both (b)(6). The (b)(6) serology result prompted the customer to perform individual sample testing (resolution pools of 1). The donor with the (b)(6) serology results was found to be mpx reactive, presumably for (b)(6). The customer only released the (b)(6) patient results obtained from the resolution pools of 1 analysis. The discrepant results obtained by the customer between the two sample pool sizes (pools of 6 and resolution pools of 1) may be explained by the different assay sensitivity of the mpx assay at different pool sizes. According to the cobas taqscreen mpx package insert (m/n 04788397001-05, doc rev. 3. 0) the lower limit of detection (lod) of the (b)(6) target in the mpx assay is 3. 8 iu/ml. This lod is for individual sample testing, such as resolution pools of 1. However, when donors are pipetted as part of a pool, the lod of the mpx assay will vary according to the pool size being used. The lod of the mpx assay for a pools of 6 is approximately six times higher than the lod for individual sample testing (lod=3. 8 iu/ml * 6 =22. 8 iu/ml). In this case, the customer obtained a (b)(6) mpx result, and therefore an (b)(6) result, for a pool of 6. However, when resolution pools of 1 was used to test all six samples in the pool individually, lower individual titers that are within the range of detection of the mpx assay could be detected (lod=3. 8iu/ml). This may explain the result discrepancy observed by the customer when using different pool sizes with the mpx assay an (b)(6) viral load test was performed to further investigate the cause of the (b)(6) pools of 6 result compared with the (b)(6) serology and pools of 1 result. The customer tested the (b)(6) sample using the cobas taqman hbv high pure test (m/n 03500756 190) to obtain a viral titer. The (b)(6) sample had a titer result of (b)(6)" which confirmed that the sample contained a very low (b)(6) concentration that was detectable but not quantifiable due to the low level present in the sample. The lod for the (b)(6) high pure test is (b)(6) in plasma as noted on the package insert (m/n 03584933001-08, doc rev. 7. 0). Altogether, these findings demonstrate that the mpx assay would only be able to detect (b)(6) for the sample in question during individual sample testing but not in pools (e. G. Pools of 6) with 95% confidence. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00090 |
| MDR Report Key | 2283959 |
| Report Source | 01,05 |
| Date Received | 2011-10-10 |
| Date of Report | 2011-11-07 |
| Date of Event | 2011-09-20 |
| Date Mfgr Received | 2011-11-03 |
| Date Added to Maude | 2012-07-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 TAQSCREEN MPX TEST |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2011-10-10 |
| Catalog Number | 04584244190 |
| 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 | 2011-10-10 |