MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-07 for COBAS AMPLISCREEN HBV TEST, US-IVD 03599779190 manufactured by Roche Molecular Systems.
[1455632]
The customer did indicate that they believe that the organ was transplanted.
Patient Sequence No: 1, Text Type: D, B5
[8504639]
Corrected data / additional information: method, result and conclusion were updated to reflect the outcome of the complaint investigation. As reported by the customer, and observed within the customer data, the customer is not adhering to the interpretation of results criteria outlined within the product labeling. The customer specified that their testing protocol is as follows: the customer requests two collections from a donor. Upon receipt, one collection is tested in duplicate (separate extractions). If one test is positive and one test is negative, the site, utilizing the second collection tube, performs an additional duplicate test run (separate extractions). If both tests from the second collection tube are negative, the site releases the donation as hbv negative. As indicated within the product labeling, the cobas(r) ampliscreen hbv test is a qualitative in vitro diagnostic test for the direct detection of hepatitis b virus (hbv) dna in human plasma. The test is intended to be used to screen donors of hbv in addition to the currently recommended serology tests. The test is intended for use as a donor screening test for the following samples types: plasma samples from individual human donors, including donors of whole blood and blood components, source plasma and other living donors. Organ donors when specimens are obtained while the donor's heart is still beating. Blood specimens from cadaveric (non-heart beating) organ and tissue donors. The test can be considered a supplement test that confirms hbv infection for specimens that are repeatedly reactive on a licenses donor screening test for hepatitis b surface antigens, and reactive on the cobas(r) ampliscreen hbv test. Within the product labeling, the interpretation of results for individually tested specimens is as follows: if an individual or cadaveric specimen is positive, the specimen is reported as "hbv dna positive. " if an individual or cadaveric specimen is negative, the specimen is reported as "hbv dna negative. " note: as there is no retest algorithm for individual specimens that initially test positive for hbv dna, these specimens, in accordance with the product labeling, should be reported as "hbv dna positive. " investigation into this issue included 2 customer site visits and a review of product performance data (investigative testing with retain material, quality control data and complaint history data). During 2 separate customer site visits, a field service representative and subsequently a representative from global systems support both indicated that the laboratory was disorganized and dusty. The fsr also indicated that the laboratory technicians were not very diligent about cleaning. These findings support the notion that the discrepant results observed at the customer site are likely due to contamination (suboptimal sample handling and/or processing). There was no batch or product non-conformance identified during the review of product performance data; retention material was within specification, quality control testing was within specification and no prior complaint cases were identified during the complaint history analysis. Although performing the cobas(r) ampliscreen hbv test off-label (i. E. , failure to follow instructions with regard to result interpretation) may potentially result in the release of hbv positive donor material, for this specific case it appears as though the (b)(6) results generated with the cobas(r) ampliscreen hbv test were due to suboptimal laboratory conditions. Additionally, at this time, there has been no indication that (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[18242716]
Results for 4 samples (donor organs; cadaveric samples) that were tested individually with the cobas ampliscreen hbv test us-ivd initially tested (b)(6) for hbv dna; however, during repeat testing, the 4 samples tested (b)(6) for hbv dna. Based on the (b)(6) test results, and eia results, the organs are designated as hbv (b)(6) and released for transplant. The customer does not have any information regarding the organ donation or the organ recipient's health (if transplanted).
Patient Sequence No: 1, Text Type: D, B5
[18360725]
Upon review of the customer provided data, it was determined that the initial test result for sample (b)(6) was invalid due to an invalid (b)(6) control replicate. Therefore, there were no valid, discrepant results generated for this sample. As stated within the product labeling for the cobas ampliscreen hbv test, for a cadaveric sample, if the individual cadaveric specimen is positive, the positive cadaveric sample is to be reported as "hbv dna positive". As indicated by the customer site, the customer ignored the original hbv dna (b)(6) results generated for specimens (b)(6) and repeat tested these specimens. Repeat test generated hbv dna (b)(6) results. As these specimens were also eia (b)(6), the customer reported that these specimens were hbv dna (b)(6). This practice is off-label and it not supported within the cobas ampliscreen hbv test labeling. Futher communication with the customer site revealed that the customer did not have any remaining material for specimens (b)(6), and therefore, roche would not be able to perform investigative testing with the cadaveric specimens. Further investigation into this issue is being performed and a more thorough conclusion will be drawn once the investigation has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2009-00014 |
| MDR Report Key | 1494200 |
| Report Source | 05 |
| Date Received | 2009-10-07 |
| Date of Report | 2009-12-01 |
| Date of Event | 2009-08-24 |
| Date Mfgr Received | 2009-09-16 |
| Date Added to Maude | 2009-12-11 |
| 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 | MRS. LEXIE PIEPER |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537855 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLISCREEN HBV TEST, US-IVD |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2009-10-07 |
| Catalog Number | 03599779190 |
| Lot Number | L00387 |
| Device Expiration Date | 2010-05-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2009-10-07 |