MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-05-02 for COBAS AMPLLIPREP / COBAS TAQMAN CMV TEST CE-IVD 04902068190 manufactured by Roche Molecular Systems.
[4434440]
A customer in (b)(6) filed a complaint alleging that an over-quantitated cmv titer of 121,000 iu/ml was generated for one patient sample using the cobas ampliprep / cobas taqman (cap/ctm) cmv test. Three separate patient samples from the same patient were tested. The initial sample, run on (b)(6) 2014, generated a cmv titer of 916 iu/ml. A second sample was run on (b)(6) 2014 and generated a titer of 121,000 iu/ml. When repeated the same day, the titer was 160 iu/ml. A third sample was run on (b)(6) 2014 and generated a titer of 1070 iu/ml. It was stated in the complaint that the patient was (b)(6) tested by elisa and nat but is (b)(6) (testing dates, test used and data not provided). This mdr is being submitted for the cmv result of 122,000 iu/ml.
Patient Sequence No: 1, Text Type: D, B5
[11846381]
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. Associated us product 04902025190 p110037. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34939906]
Date of this report 19-jun-2014. Description of event - updated to indicate that an additional data point was provided for the patient. Relevant tests/laboratory data, including dates - updated to include additional data point for the patient. Date additional information was received by manufacturer (19-jun-2014). Follow up report additional information/correction/device evaluation. Device evaluated by manufacturer: yes. (b)(4). A customer in chile alleged discrepant results with the cobas ampliprep/cobas taqman (b)(6) test for samples taken from the same patient. Results for the different collections were: (b)(6). It was noted that the customer does not perform daily maintenance of their instrumentation as prescribed in the product's labeling. Testing of the retain kit in question met specifications, and no issues were identified during release of the kit. The samples for this patient were not available for return, so the cause for the over-quantitation could not be further investigated or identified. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[34939907]
Within the initial mdr 2243471-2014-00013, it was indicated that 4 test results from 3 samples collected from the same patient generated differing results with the cobas ampliprep/cobas taqman (cap/ctm) (b)(6) test. Over the course of the investigation, it was determined that 5 test results were generated for this patient. The 5th test result (631 iu/ml) was generated on (b)(6) 2014 with the first sample collected from this patient. This mdr follow-up is being submitted to address the over-quantitated result (121,000 iu/ml) originally reported in the initial mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2014-00013 |
| MDR Report Key | 3787255 |
| Report Source | 01,05 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-05-01 |
| Date Mfgr Received | 2014-06-19 |
| Date Added to Maude | 2014-06-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 AMPLLIPREP / COBAS TAQMAN CMV TEST CE-IVD |
| Generic Name | CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY |
| Product Code | PAB |
| Date Received | 2014-05-02 |
| Catalog Number | 04902068190 |
| Lot Number | S10963 |
| Device Expiration Date | 2014-12-31 |
| 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 | 2014-05-02 |