MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-15 for ABBOTT PRISM HIV O PLUS ASSAY 3L68 manufactured by Abbott Diagnostics.
[1646000]
The specificity & the positive predictive value of (b) (6) testing at the (b) (6) testing laboratories-(b) (6)- have decreased since implementation of the abbott prism hiv o plus assay. Repeat reactive -rr- rates have unexpectedly increased from 0. 04% on the abbott (b) (4) that had been used since (b) (6) 1992 to 0. 11% on the abbott prism hiv o plus assay, resulting in 1067 donor deferrals. This increase has been observed by all (b) (6) over the first 6 assay lots, as well as by abbott diagnostics, which has received complaints for increased rr rates from other blood centers using the prism system. The assay package insert lists abbott studies for volunteer donor serum samples with mean rrs of 0. 03% and a 95% confidence interval of 0. 00-0. 11%. The arc has initiated a formal product complaint with abbott and is working with them to help resolve the issue. Abbott has been given access to instrument data and to date, there has been no significant variable identified based on statistical analysis of variation by (b) (6), by lot, or by prism serial number. On approx 04/01/2010, the arc shipped (b) (4) hiv o plus rr units -unconfirmed- to abbott for their investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015600 |
| MDR Report Key | 1664424 |
| Date Received | 2010-04-15 |
| Date of Report | 2010-04-15 |
| Date of Event | 2010-01-25 |
| Date Added to Maude | 2010-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT PRISM HIV O PLUS ASSAY |
| Generic Name | BLOOD DONOR SCREENING ASSAY |
| Product Code | MTP |
| Date Received | 2010-04-15 |
| Catalog Number | 3L68 |
| Lot Number | 79781M101 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | ABBOTT PARK IL 60064608 US 60064 6083 |
| Brand Name | ABBOTT PRISM HIV O PLUS ASSAY |
| Generic Name | BLOOD DONOR SCREENING ASSAY |
| Product Code | MTP |
| Date Received | 2010-04-15 |
| Lot Number | 80236M101 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | ABBOTT PARK IL 60064608 US 60064 6083 |
| Brand Name | ABBOTT PRISM HIV O PLUS ASSAY |
| Generic Name | BLOOD DONOR SCREENING ASSAY |
| Product Code | MTP |
| Date Received | 2010-04-15 |
| Lot Number | 80889M100 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | ABBOTT PARK IL 60064608 US 60064 6083 |
| Brand Name | ABBOTT PRISM HIV O PLUS ASSAY |
| Generic Name | BLOOD DONOR SCREENING ASSAY |
| Product Code | MTP |
| Date Received | 2010-04-15 |
| Lot Number | 80889M101 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | ABBOTT PARK IL 60064608 US 60064 6083 |
| Brand Name | ABBOTT PRISM HIV O PLUS ASSAY |
| Generic Name | BLOOD DONOR SCREENING ASSAY |
| Product Code | MTP |
| Date Received | 2010-04-15 |
| Lot Number | 82663M100 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | ABBOTT PARK IL 60064608 US 60064 6083 |
| Brand Name | ABBOTT PRISM HIV O PLUS ASSAY |
| Generic Name | BLOOD DONOR SCREENING ASSAY |
| Product Code | MTP |
| Date Received | 2010-04-15 |
| Lot Number | 83433M500 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | ABBOTT PARK IL 60064608 US 60064 6083 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-15 |