MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-11 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-68 manufactured by Abbott Laboratories.
[844421]
The account generated repeatedly reactive abbott hiv-1/2 eia results on a patient who tested western blot negative. In 2008, the patient tested abbott hiv-1/2 eia repeatedly reactive (>2. 0 s/co) but hiv negative at a reference laboratory. Additionally, the specimen tested western blot hiv-1 negative. On the following month, a new specimen was obtained and again tested abbott hiv-1/2 eia reactive (>2. 0 s/co) but western blot hiv-1 nad hiv-2 negative. The abbott hiv-1/2 eia controls and external controls are within range. The patient is a dialysis patient and is very sick. No further patient data is available. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[7993120]
This is an initial report. An investigation is in progress. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[8136439]
(b)(4) - a review of product complaint data along with a product labeling review determined that a product deficiency is not likely. Acceptance criteria were met for the complaint tracking and trending review. The issue of specimens that are initially and repeatedly reactive and negative or indeterminate on supplemental testing is addressed in the abbott hivab hiv-1/hiv-2 (rdna) eia package insert. The interpretation of results section of the package insert states: "specimens found to be repeatedly reactive by abbott hivab hiv-1/hiv-2 (rdna) eia must be investigated by additional, more specific supplemental tests. " additionally, it states: "the interpretation of results of specimens found to be repeatedly reactive by abbott hivab hiv-1/hiv-2 (rdna) eia and negative or indeterminate on additional more specific supplemental testing is unclear; further clarification may be obtained by testing another specimen taken three to six months later. " investigation: a complaint tracking and trending review was performed to determine if there were any trends related to the complaint under investigation or any additional issues related to the complaint. The acceptance criteria were met. The review of this data did not identify any problems. Specifically, there was no increase in the number of complaints related to an increase in initial reactive rates and repeat reactive rates while using the reagent lot numbers in question. Although the investigation team did not find any product deficiency, abbott will take further action by referring the customer to the abbott hivab hiv-1/hiv-2 (rdna) eia package insert. The interpretation of results section of the package insert states: "specimens found to be repeatedly reactive by abbott hivab hiv-1/hiv-2 (rdna) eia must be investigated by additional, more specific supplemental tests. " additionally, it states: "the interpretation of results of specimens found to be repeatedly reactive by abbott hivab hiv-1/hiv-2 (rdna) eia and negative or indeterminate on additional more specific supplemental testing is unclear; further clarification may be obtained by testing another specimen taken three to six months later. " based on the overall investigation, the abbott hivab hiv-1/hiv-2 (rdna) eia assay is performing acceptably. Although we cannot provide a specific reason for the observed increase in initial reactive rates and repeat reactive rates, abbott is continuing to monitor this assay for product issues in our ongoing effort to provide the highest quality diagnostic products and support. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00054 |
| MDR Report Key | 1029610 |
| Report Source | 05 |
| Date Received | 2008-04-11 |
| Date of Report | 2008-03-18 |
| Date of Event | 2008-02-25 |
| Date Mfgr Received | 2008-10-21 |
| Device Manufacturer Date | 2007-12-06 |
| Date Added to Maude | 2008-11-20 |
| 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. KHAUDEJA BANO |
| Manufacturer Street | 100 ABBOTT PARK ROAD D09Y6, AP6C-2 |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479386319 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| 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 | IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HIV-1 AND HIV-2 ANTIBODIES |
| Product Code | LRM |
| Date Received | 2008-04-11 |
| Model Number | NA |
| Catalog Number | 3A77-68 |
| Lot Number | 59025M200 |
| ID Number | NA |
| Device Expiration Date | 2008-04-02 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1030473 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-11 |