MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-24 for DETERMINE HIV - 1/2 AG/AB COMBO * 7D2648 manufactured by Alere Orgenics Ltd.
[6072186]
Rapid hiv testing was done on patients with a new test p24 (new standard of testing). The results on 3 different patients came back with a positive antigen. We did further testing to confirm this test which showed a final result as negative. We discussed this issue with lab and they got a different lot number of the tests and re-ran those 3 specimens with a result of negative. We ended up treating patients unnecessarily and scaring them for a false test result. There were 4 incidents all together:1st patient safety report: rapid hiv test run on patient. P24 antigen came back positive. Patient notified and further testing was done. Patient and newborn treated. Final testing came back negative. Patient had a cescarian section. Discussed in future dci (document center interface computer documentation system) about getting more false positives. Lab tested under new lot number and the result was negative. Working with company for new product. 2nd report: rapid hiv testing done on patient. P24 antigen came back with a false positive. Further testing showed result as negative. Brought up in dci and lab researched using a different lot number and obtained a negative result. The company was notified and new product was ordered. Patient's record corrected. 3rd incident: rapid hiv testing done and showed a positive antigen with p24 testing. The test was questioned with so many false positives showing up. Lab retested sample on a different lot number and the result was negative. Lab working with company to get different product. Plan in place to re-run the test if p24 antigen is positive. Risk and lab aware of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4894266 |
| MDR Report Key | 4894266 |
| Date Received | 2015-06-24 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-06-11 |
| Report Date | 2015-06-24 |
| Date Reported to FDA | 2015-06-24 |
| Date Reported to Mfgr | 2015-07-07 |
| Date Added to Maude | 2015-07-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DETERMINE HIV - 1/2 AG/AB COMBO |
| Generic Name | LAB TEST |
| Product Code | MTL |
| Date Received | 2015-06-24 |
| Model Number | * |
| Catalog Number | 7D2648 |
| Lot Number | 150507 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE ORGENICS LTD |
| Manufacturer Address | 10 SOUTHGATE RD SCARBOROUGH ME 04074 US 04074 |
| Brand Name | DETERMINE HIV - 1/2 AG/AB COMBO |
| Generic Name | LAB TEST |
| Product Code | MTL |
| Date Received | 2015-06-24 |
| Model Number | * |
| Catalog Number | 7D2648 |
| Lot Number | 150507 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ALERE ORGENICS LTD |
| Manufacturer Address | 10 SOUTHGATE RD SCARBOROUGH ME 04074 US 04074 |
| Brand Name | DETERMINE HIV - 1/2 AG/AB COMBO |
| Generic Name | LAB TEST |
| Product Code | MTL |
| Date Received | 2015-06-24 |
| Model Number | * |
| Catalog Number | 7D2648 |
| Lot Number | 150507 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ALERE ORGENICS LTD |
| Manufacturer Address | 10 SOUTHGATE RD SCARBOROUGH, ME 04074 US 04074 |
| Brand Name | DETERMINE HIV - 1/2 AG/AB COMBO |
| Generic Name | LAB TEST |
| Product Code | MTL |
| Date Received | 2015-06-24 |
| Model Number | * |
| Catalog Number | 7D2648 |
| Lot Number | 150507 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | ALERE ORGENICS LTD |
| Manufacturer Address | 10 SOUTHGATE RD SCARBOROUGH, ME 04074 US 04074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-24 |