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 2019-03-12 for PRISM HTLV-I/HTLV-II 06A53-48 manufactured by Abbott Laboratories.
[142394101]
Patient identifier = sid (b)(6). An evaluation is in process. A final report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 6a53 that has a similar product distributed in the us, list number 6e50. There is no further donor information provided due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[142394102]
The customer reported (b)(6) prism htlv results on one sample during a correlation study. The results provided were: on prism on (b)(6) 2018 sid (b)(6) = (b)(6) / on (b)(6) 2018 = (b)(6); confirmatory testing was inconclusive. There was no reported impact to patient/donor management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2019-00016 |
| MDR Report Key | 8413007 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-29 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-03-12 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM HTLV-I/HTLV-II |
| Generic Name | HTLV-I/ HTLV-II ANTIBODIES |
| Product Code | MTP |
| Date Received | 2019-03-12 |
| Catalog Number | 06A53-48 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |