MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-21 for PRISM HTLV-I/HTLV-II 06E50-68 manufactured by Abbott Laboratories.
[26561955]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26561956]
The mother of a (b)(6) female blood donor called to report a false reactive result generated for her daughter's screening on an abbott prism analyzer with the abbott prism htlv-i/htlv-ii assay during the first week of (b)(6) 2015 (exact date unknown). A letter was received from the american red cross stating that her daughter was deferred as a blood donor due to the reactive result generated on the abbott prism htlv-i/htlv-ii assay. Her daughter's sample was then screened by a different methodology and generated a non-reactive result. On behalf of the donor, abbott contacted the american red cross (charlotte) and asked them to follow up with the donor/mother contact and explain what she needs her provider to do to have her daughter reinstated as a donor that may include any further confirmatory testing. There was no medical treatment administered to the donor as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[28095210]
There were no returns from the customer site for this evaluation. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. A review of the device history record for the suspect reagent lot did not reveal any issues related to the customer's observations. A review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott prism htlv-i/-ii product are less than the package insert upper 95% confidence intervals (meets specificity claims). The abbott prism htlv-i/-ii assay package insert contains information to address the customer's current issue. Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred. This evaluation indicates that the product is performing as expected; there is no product deficiency. No new performance issues were identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2015-00033 |
| MDR Report Key | 5090997 |
| Date Received | 2015-09-21 |
| Date of Report | 2015-09-25 |
| Date Mfgr Received | 2015-09-25 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-09-21 |
| 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 |
| Product Code | MTP |
| Date Received | 2015-09-21 |
| Catalog Number | 06E50-68 |
| Lot Number | 52039M500 |
| Device Expiration Date | 2016-04-09 |
| 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 | 2015-09-21 |