MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2007-12-28 for HIVAB HIV-1/HIV-2 (RDNA)EIA 3A77-68 manufactured by Abbott Laboratories.
[749553]
The customer stated they had twelve samples that were reactive on initial on the quantum ii with lot #55425m100 and lot # 55896m100. The samples were all low level reactive, just above the cut off. The samples were sent out for confirmatory testing and came back western block negative. The customer stated that quantum maintenance is up to date. They have cultured their water source with no growth indicated and the tubing is clear and not damaged. No medical history was available for the pt samples. A follow-up with the customer on 12/5/2007 revealed that the customer had received several more low level reactive results. Repeat testing on a different lot was negative. The customer provided data for six of the twelve pts. This data is for pt five of six. Quantum ii reactive at 2. 000 absorbance value and western block negative. No impact to pt mgmt was reported.
Patient Sequence No: 1, Text Type: D, B5
[8090324]
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 | 1415939-2007-00278 |
| MDR Report Key | 970828 |
| Report Source | 04,05 |
| Date Received | 2007-12-28 |
| Date of Report | 2007-11-29 |
| Date Mfgr Received | 2007-11-29 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2008-03-18 |
| 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 | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIVAB HIV-1/HIV-2 (RDNA)EIA |
| Generic Name | EIA FOR DETECTION OF AB TO HIV I AND II |
| Product Code | LRM |
| Date Received | 2007-12-28 |
| Model Number | NA |
| Catalog Number | 3A77-68 |
| Lot Number | 55896M100 |
| ID Number | NA |
| Device Expiration Date | 2007-12-09 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 973554 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-28 |