MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-11-12 for HIVAB HIV-1/HIV-2 (RDNA) EIA 03A77-25 manufactured by Abbott Laboratories.
[3938995]
A public individual contacted abbott on (b)(6) 2013, inquiring about the clinical utility and intended use of abbott (b)(4) tests and which test diagnoses (b)(6). The individual stated that in 1996, a doctor confirmed her husband as having (b)(6) because an abbott test (assay unknown) read (b)(6). No test results were provided. The individual stated that when her husband died, they found no (b)(6). No information on test methods performed was supplied. Abbott had a follow-up conversation with this individual on (b)(6) 2013. The individual stated that in 1996, (b)(4) testing (unknown abbott method) was performed by a laboratory located in (b)(6). Additional testing was performed using a roche method (pcr viral load) but results were not known. At that time, the physician told the patient that he had the (b)(6). The individual stated her husband was retested in 2012 and 2013 by a hospital in (b)(6) by electromicroscope. Both tests reported (b)(6) viral particles and (b)(6) budding retrovirus. The individual stated that when her husband died on (b)(6) 2013, no (b)(6) was found. It is not known if the patient was being monitored or treated for (b)(6) between 1996 and 2013.
Patient Sequence No: 1, Text Type: D, B5
[11338321]
(b)(4). Abbott laboratories cannot confirm that an abbott test was used in 1996 to test the patient for (b)(6). However, this event is being submitted under catalog # 03a77 ((b)(6)) eia as this product was available in 1996. An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00389 |
| MDR Report Key | 3462855 |
| Report Source | 00 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-09-14 |
| Date of Event | 1996-01-01 |
| Date Mfgr Received | 2013-10-15 |
| Date Added to Maude | 2014-02-07 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| 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 |
| Product Code | LRM |
| Date Received | 2013-11-12 |
| Catalog Number | 03A77-25 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-12 |