MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-12 for COBAS TAQSCREEN MPX TEST V2.0 US-IVD 05969484190 manufactured by Roche Molecular Systems.
[75333814]
The investigation into this issue is currently on-going. The outcome of this investigation will be communicated through a follow-up report. The udi for the cobas taqscreen mpx test, v2. 0 us-ivd is: 00875197004045. The product common name was truncated and the complete name is (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75333815]
The customer alleged an increased frequency of unexpected reactivity in donor sample results using the cobas taqscreen mpx test, v2. 0 us-ivd, starting the month of (b)(6) 2017. The customer alleged this event has led to multiple donation losses, including blood, organ and cadaveric tissue donations. The customer reported the event to the fda. Four kit lots were involved in the customer allegation. This mdr is for kit lot x12815.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2017-00015 |
| MDR Report Key | 6563578 |
| Date Received | 2017-05-12 |
| Date of Report | 2018-01-26 |
| Date of Event | 2017-04-01 |
| Date Mfgr Received | 2017-04-14 |
| Date Added to Maude | 2017-05-12 |
| 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 STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS TAQSCREEN MPX TEST V2.0 US-IVD |
| Generic Name | HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV |
| Product Code | MTL |
| Date Received | 2017-05-12 |
| Model Number | NA |
| Catalog Number | 05969484190 |
| Lot Number | X12815 |
| ID Number | NA |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 1080 US HWY 202 S NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-12 |