MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-10-26 for COBAS TAQSCREEN MPX TEST 04584244190 manufactured by Roche Molecular Systems.
[1692149]
A customer in (b)(6) (blood screening center (b)(6)) reported that a false (b)(6) test result with the cobas taqscreen mpx test lead to the transfusion of (b)(6) positive donor material. The donor specimen, (b)(6), was originally tested with the cobas taqscreen mpx test on (b)(6)2010. The test result from this donation was non-reactive for (b)(6). Additionally, the donation was hbsag non-reactive, anti-hcv non-reactive and anti-hiv non-reactive. On (b)(6) 2010, a (b)(6) female received a blood donation that included material from (b)(4). On (b)(6) 2010, the blood screening center in (b)(6) was informed that the (b)(6) female was hospitalized due to an (b)(6) infection. The (b)(6) female remained in the hospital for 15 days. Details on her current state of health are unknown. On (b)(6) 2010, the customer site performed retests of the donor material that the (b)(6) female received. Upon retest, (b)(6) was reactive with the cobas taqscreen mpx test. At this time it is unknown which analyte (b)(6) contributed to the reactive result that was observed as the cobas taqscreen mpx test cannot differentiate between (b)(6). However, the customer speculated that the reactive cobas taqscreen mpx test result was due to the detection of (b)(6). The customer made this assessment based on the (b)(6) infection identified with the recipient of the donor material from (b)(6). The reactive donation was sent to a reference laboratory for additional testing on (b)(6) 2010. Results from the reference laboratory are pending.
Patient Sequence No: 1, Text Type: D, B5
[8856678]
No conclusion can be drawn at this time as the investigation into this issue is ongoing. The outcome of the investigation into this issue will be reported 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
[17913684]
(b)(4) analysis of donor specimen. During the investigation into this issue, an analysis of the lcii hbv-dna test was performed by a reference lab specified by the customer. As specified by the customer, the sensitivity of the lcii hbv-dna test was calculated with the probit analysis method using the who 1st international standard for hbv-dna. The sensitivity was measured to be 22 iu/ml at the 95% confidence interval and 8. 4 iu/ml at the 50% confidence interval. However, precision and linearity data were not available for the lcii hbv-dna test, and therefore, a statistical analysis, by roche molecular systems, of the test's performance could not be performed. Without additional data, it is not possible to determine whether or not the lcii hbv-dna test variability could result in a donor specimen with an hbv dna concentration (b)(6). (b)(4). The cobas taqscreen mpx test should detect hbv dna at >98. 5%. (b)(4). Although this is below the test's performance claims, the sampling size (n=2) is not sufficient to perform a thorough statistical analysis. Additionally, although requested, additional donor material was not available for analysis. Additionally, the investigation into this issue determined that the complaint kit lot is performing as per the product labeling; there was no non-conformance / malfunction identified. Verification testing was performed and the kit lot met performance specifications despite the kit being tested 1 month past expiration. Additionally, there were no additional complaint cases filed alleging false (b)(6) hbv test results between two cobas taqscreen mpx test runs. It is not possible, with the limited data available, to be able to confidently demonstrate a (b)(4) event. (b)(4). In regions of high prevalence, sample handling is critical due to issues of cross-contamination. (b)(4). In the present case, while three of the four implicated donors were traced and follow-up samples taken, the fourth donor has not yet been traced. The follow-up samples from the three donors were (b)(6) for hbv. Pre- and post-transfusion samples from the recipient were available and indicated that the recipient was hbv (b)(6) pre-transfusion. However, hbv sequence data of the recipient sample are not available. Although it was reported that a patient (b)(6) due to a false (b)(6) cobas taqscreen mpx test result, there is no indication of a product or batch non-conformance / malfunction, no field actions are necessary. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00042 |
| MDR Report Key | 1883451 |
| Report Source | * |
| Date Received | 2010-10-26 |
| Date of Report | 2010-12-22 |
| Date of Event | 2010-04-16 |
| Date Mfgr Received | 2010-12-22 |
| Device Manufacturer Date | 2009-12-22 |
| Date Added to Maude | 2011-01-04 |
| 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 | 2010-10-26 |
| Catalog Number | 04584244190 |
| Lot Number | M12236 |
| Device Expiration Date | 2010-09-30 |
| 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 | 1. Hospitalization; 2. Other | 2010-10-26 |