MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-25 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[15862373]
The customer stated a blood donor generated initial and repeat reactive results of 1. 09, 1. 09 and 1. 14 s/co on the prism chagas assay but did not confirm by ripa and was also nonreactive on an alternate screening method. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[15941093]
(b)(4). Customer complaints received to-date were reviewed and did not identify any adverse trend in reports related to false reactive results. In addition, field data was reviewed to evaluate clinical specificity. The results of the field data review demonstrated that lot # 09900m500 is performing as intended for clinical specificity as measured by reactive rates. Based on the results of this investigation, the abbott prism chagas reagents, list number 7k35-68, are performing as intended and no additional product issues were identified. The customer was referred to the prism chagas package insert under limitations of the procedure for further information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2012-00164 |
| MDR Report Key | 2548370 |
| Report Source | 05 |
| Date Received | 2012-04-25 |
| Date of Report | 2012-04-05 |
| Date of Event | 2012-03-14 |
| Date Mfgr Received | 2012-04-05 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2012-09-10 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | PRISM CHAGAS |
| Product Code | MIU |
| Date Received | 2012-04-25 |
| Catalog Number | 07K35-68 |
| Lot Number | 09900M500 |
| Device Expiration Date | 2012-08-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-04-25 |