MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-05-25 for PRISM CHAGAS 7K35-48 manufactured by Abbott Laboratories.
[2146285]
The customer states that one patient has generated false positive prism chagas results on two separate samples. On (b)(6) 2011, prism chagas positive results of 12. 86 s/co (serum) and 13. 51 s/co (plasma) were generated. This sample generated negative chagas results with three other platforms. Pcr testing was negative. This patient generated negative prism chagas results in (b)(6) 2010. On (b)(6) 2011, this same patient generated a positive prism chagas result of 12. 17 s/co with a second serum sample. This second sample tested negative on the same three alternate platforms as the month before. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[9077992]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete. This report is being filed on an international product, (b)(4) that has a similar product distributed in the us, (b)(4). Other concomitant medical device: prism chagas(row) ln:7k35-48 lot#:96623m500.
Patient Sequence No: 1, Text Type: N, H10
[9476122]
The customer returned one sample from the patient in question. The returned patient sample was tested per the prism chagas package insert. Since the reagent lots documented in the complaint had expired and the issue was not lot specific, approved reagent lot 03282m500 was used for the assay. The initial and retest results of the sample reproduced the positive results observed by the customer. Since there is no approved confirmatory test method for chagas, no further evaluation of the sample could be performed. To evaluate clinical specificity a review of field data reported to our prism metrics database from customers using the prism chagas assay was completed. For this review the field data for reagent lots 89135m500 and 94830m500 were reviewed. Reagent lot 89135m500 has the same components as lot 90394m500 and reagent lot 94830m500 has the same active components as lot 96623m500. For reagent lot 89135m500, (b)(4). Complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The abbott prism chagas assay package insert, commodity 34-6086/r03, contains information to address the customer's current issue. The current investigation determined that the abbott prism chagas assay is performing as intended and meeting its safety, effectiveness and label claims. A product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00163 |
| MDR Report Key | 2103170 |
| Report Source | 01 |
| Date Received | 2011-05-25 |
| Date of Report | 2011-05-18 |
| Date of Event | 2011-03-01 |
| Date Mfgr Received | 2011-09-28 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2012-04-05 |
| 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 | 8479375120 |
| 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 |
| Generic Name | FOR THE DETECTION OF ANTIBODIES TO T. CRUZI |
| Product Code | MIU |
| Date Received | 2011-05-25 |
| Catalog Number | 7K35-48 |
| Lot Number | 90394M500 |
| Device Expiration Date | 2011-04-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-05-25 |