MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-01-11 for COBAS? TAQSCREEN MPX TEST, VERSION 2.0 CE-IVD TEST 05969492190 manufactured by Roche Molecular Systems.
[64519581]
Through the customer? S internal investigation, the donor contains a low (b)(6) viral load. Roche has determined that there is no product malfunction as the donor sample contains a low concentration of (b)(6) that would not be reproducibly detected as it is below the limit of detection of the cobas taqscreen mpx test, v2. 0 ce-ivd. There is no indication that this situation led to death or serious injury. The customer continues to investigate the situation. If additional information becomes available that indicates death or serious injury, a supplemental medical device report will be filed. The udi for cobas taqscreen mpx test, v2. 0 ce-ivd is (b)(4). In outcomes attributed to adverse events, "other serious" was selected. No serious injury or harm has been reported to date and an investigation is on-going by the customer site. No other selections were appropriate for this situation. (b)(4). Roche has determined that there is no product malfunction as the donor sample contains a low concentration of (b)(6) that would not be reproducibly detected as it is near or below the limit of detection of the cobas taqscreen mpx test, v2. 0 ce-ivd test.
Patient Sequence No: 1, Text Type: N, H10
[64519582]
A hospital in lithuania alleged false non-reactive results for a donor when tested with the cobas taqscreen mpx test, v2. 0 ce-ivd in a pool of 6. Donations from this donor were transfused into recipients prior to recent (b)(6) reactive results obtained in (b)(6) 2016 using the cobas taqscreen mpx test, v2. 0 ce-ivd (pools of 6 and 1). Through the customer? S internal investigation, the donor contains a low (b)(6) viral load. Roche has determined that there is no product malfunction as the donor sample contains a low concentration of (b)(6) that would not be reproducibly detected as it is near or below the limit of detection of the cobas taqscreen mpx test, v2. 0 ce-ivd test. There is no indication that this situation led to death or serious injury. The customer continues to investigate the situation. If additional information becomes available that indicates death or serious injury, a supplemental medical device report will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2017-00001 |
| MDR Report Key | 6242148 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-11 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2017-01-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA TIMOTHY BLAIR |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537918 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS? TAQSCREEN MPX TEST, VERSION 2.0 CE-IVD TEST |
| Generic Name | NA |
| Product Code | MZP |
| Date Received | 2017-01-11 |
| Model Number | NA |
| Catalog Number | 05969492190 |
| Lot Number | 219650 |
| ID Number | NA |
| Device Expiration Date | 2017-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 S NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-11 |