MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-02-16 for COBAS TAQSCREEN MPX TEST 04584244190 manufactured by Roche Molecular Systems.
[1714706]
On the (b)(6)-2011, we were informed by the (b)(6) that a false (b)(6) result was generated for hbv with the cobas taqscreen mpx test. The customer indicated that a donor made a blood donation on (b)(6)-2010, which was tested on (b)(6)-2010. The donation tested (b)(6) with the cobas taqscreen mpx test and serological (b)(6) for hbsag, hiv and hcv. (b)(6). The above donor donated again after 3 months ((b)(6)-2011). The result from the serological screening was (b)(6) for hbsag, hiv and hcv. The blood tested with the cobas taqscreen mpx test on (b)(6)-2011 and the donation was (b)(6). The second tube from the same draw was received on (b)(6)-2011 and tested (b)(6) with the cobas taqscreen mpx test on (b)(6)-2011. Furthermore, the fresh frozen plasma (ffp) from the same donation tested (b)(6) with the cobas taqscreen mpx test. On (b)(6)-2011 the original donation (serum specimen), from (b)(6)-2010, was tested for anti-hbv core antibody (hbc) and the donation was (b)(6). It was reported by the customer that (b)(6), the donation recipient was anti-hbc (hbv core antibody) (b)(6) and anti-hbs (hbv surface antigen) (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9027676]
Follow up report 1. Additional information / device evaluation. Device evaluated by manufacturer: yes. (b)(4) - device performed according to specification. (b)(4) - no failure detected and product within specification. The customer alleged a (b)(6) test result for a donor sample ((b)(6) 2010) when compared to a (b)(6) result for a second donation ((b)(6) 2011) from the same donor and (b)(6) testing for (b)(6). The customer indicated that a (b)(6) man donated blood on (b)(6) 2010, which was transfused into a (b)(6) patient on (b)(6) 2010. Before the donation, the patient was (b)(6) and was known to have been previously infected with hbv, as testing in (b)(6) 2010, prior to the transfusion indicated that the patient had raised antibodies against (b)(6). The (b)(6) 2010, donation generated a hbv titer of (b)(6) (test used is unknown). The (b)(6) 2011 donation was tested with the cobas taqman hbv test for use with the high pure system and generated a titer of (b)(6). The (b)(6) 2011, donation was also tested with the cobas ampliscreen hbv, hcv, and hiv tests and generated negative results for all tests. This can be explained, as the cobas s 201 mpx test has a lower limit of detection (lod) than the cobas ampliscreen hbv test. Additionally, the titers for both donations were below the lod for the cobas ampliscreen hbv test ((b)(6)). For the cobas s 201 mpx runs conducted on the second donation ((b)(6) 2011, the ct values for the target were (b)(6) cycles. These target ct values are at the upper limit of the ct acceptance range (maximum ct is (b)(6)), which is indicative of a low level infection. The investigation determined that the discrepant (b)(6) result with the first donation ((b)(6) 2010) is likely due to a low hbv titer present. There is no indication of a product or batch non-conformance as: according to the cobas taqscreen mpx test for use on the cobas s 201 system package insert: (b)(6) can be expected to generate a (b)(6) result between (b)(6) of the time. This indicates that there is a small percentage of time that the sample may generate a (b)(6) result to do the (b)(6) concentration. Within the procedural limitations section, detection of (b)(6) is dependent on the number of virus particles present in the specimen and may be affected by specimen collection methods, patient factors ( i. E. , age, presence of symptoms), and / or stage of infection and pool size. Since the concentration is (b)(6) and information regarding the specimen collection and /or patient factors is unknown, it is possible that the sample may generate a (b)(6) result. Within the (b)(6) panels subsection, it indicates that the cobas taqscreen mpx test on neat and 1:6 dilution samples detected (b)(6) prior to detection of the respective antibody targets with the other two tests. For this complaint case, the second donation generated (b)(6) cobas taqscreen mpx test results as well as (b)(6) tests, specifically (b)(6), indicating that the donor may have (b)(6) between the time of the first and second donations. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9041328]
The investigation into this issue is on-going. The conclusion from the investigation will be provided through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00005 |
| MDR Report Key | 1994120 |
| Report Source | 01,05 |
| Date Received | 2011-02-16 |
| Date of Report | 2011-02-03 |
| Date of Event | 2010-10-21 |
| Date Mfgr Received | 2011-02-03 |
| Device Manufacturer Date | 2010-04-29 |
| Date Added to Maude | 2012-05-08 |
| 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 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 | 2011-02-16 |
| Catalog Number | 04584244190 |
| Lot Number | N02762 |
| Device Expiration Date | 2011-03-31 |
| 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 | 2011-02-16 |