MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-18 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[2716542]
The customer observed false reactive chagas results while using the prism chagas assay. The customer provided the following results ((b)(6) 2012): initial 6. 38 s/co, retest 5. 13 s/co, 4. 99 s/co. The specimen was tested with the ripa method at another laboratory on (b)(6) 2012, it generated a negative result. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[9928213]
(b)(4). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[10226383]
Further investigation of the customer issue included a review of the complaint text, in-house testing, a search for similar complaints, and a review of labeling. A specificity testing protocol was executed using lot 12503m500 and met acceptance criteria which determined the reagent is performing acceptably. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information a deficiency of the prism chagas reagent list number 07k35, lot 12503m500, was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2012-00214 |
| MDR Report Key | 2580311 |
| Report Source | 05 |
| Date Received | 2012-05-18 |
| Date of Report | 2012-04-30 |
| Date of Event | 2012-03-24 |
| Date Mfgr Received | 2012-07-26 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2012-09-25 |
| 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 | PRISM CHAGAS |
| Product Code | MIU |
| Date Received | 2012-05-18 |
| Catalog Number | 07K35-68 |
| Lot Number | 12503M500 |
| Device Expiration Date | 2012-10-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-05-18 |