MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-07 for ABBOTT HTLV-I/HTLV-II EIA 7A92-24 manufactured by Abbott Laboratories.
[19895403]
The customer stated while they were performing an equipment validation on the quantum ii, abbott negative controls that were being run as patient samples generated reactive results just above the cutoff on the htlv i/ii eia. In addition, eight patient samples obtained from a reference lab that previously tested negative by biomerieux ifa, generated reactive results. This report is to document patient sample id #12 that generated a reactive absorbance result of 0. 773 based on a cutoff of 0. 439. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[20034613]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00028 |
| MDR Report Key | 992392 |
| Report Source | 05 |
| Date Received | 2008-02-07 |
| Date of Report | 2008-01-08 |
| Date of Event | 2008-01-02 |
| Date Mfgr Received | 2008-01-08 |
| Date Added to Maude | 2008-04-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUNDARSHAN HEBBAR, MD, D-3MQC, AP6B |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT HTLV-I/HTLV-II EIA |
| Generic Name | EIA FOR DETECTION OF HTLV-I/HTLV-II ANTIBODIES |
| Product Code | LRM |
| Date Received | 2008-02-07 |
| Model Number | NA |
| Catalog Number | 7A92-24 |
| Lot Number | 53004M200 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 995483 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-07 |