MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD 05969492190 manufactured by Roche Molecular Systems, Inc..
[93452024]
The investigation into this issue is currently on-going. The outcome of this investigation will be communicated through a follow-up report. The second cobas taqscreen mpx v2. 0 ce-ivd kit lot (lot 219653) used at the site has an expiration date of 31-jan-2018 the udi for the cobas taqscreen mpx v2. 0 ce-ivd is (b)(4). The material number for the cobas taqsreen mpx test, v2. 0 us-ivd is: (b)(4). The udi for the cobas taqscreen mpx test, v2. 0 us-ivd is: (b)(4). The product common name was truncated and the complete name is (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93452025]
A customer, (b)(6) alleged a (b)(6) result during use of the cobas? Taqscreen mpx version 2. 0 test. (b)(6). There is no allegation of harm/injury or death associated with this case. Blood was not released and the blood bag was discarded.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2243471-2017-00023 |
MDR Report Key | 7032655 |
Date Received | 2017-11-15 |
Date of Report | 2018-02-23 |
Date of Event | 2017-10-07 |
Date Mfgr Received | 2017-10-18 |
Date Added to Maude | 2017-11-15 |
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 |
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 | 0 |
Brand Name | COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD |
Generic Name | HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV |
Product Code | MZP |
Date Received | 2017-11-15 |
Model Number | NA |
Catalog Number | 05969492190 |
Lot Number | 210560 |
ID Number | NA |
Device Expiration Date | 2017-10-31 |
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, INC. |
Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-11-15 |