MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-18 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[5804228]
The account stated the donor sample id (b)(6) generated false reactive prism chagas results (15. 39, 14. 42, 12. 83 s/co) but tested ortho chagas confirmation negative. No impact to patient management was reported. No specific donor information was provided.
Patient Sequence No: 1, Text Type: D, B5
[13287158]
(b)(4). An evaluation is in process. A followup report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[34409396]
Udi: (b)(4). Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided the customer had a dual reactive chagas and (b)(6) sample when using abbott prism chagas, list number 7k35, lot 39515m500 and abbott (b)(6), list number 6d18, lot 45055m500. Refer to manufacturer report # 1415939-2015-00015 for (b)(6). Evaluation of complaint data for the products and reagent lots used by the customer identified normal complaint activity. Additionally, review of the device history records for the reagent lots did not reveal any issues related to the customer's observations. A label review was also performed and found labeling to adequately address the customer's issue. Finally, review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott (b)(6) and abbott prism chagas products are less than the package insert upper 95% confidence intervals. As a result, there is not enough information to reasonably suggest a malfunction (within performance claims). This investigation indicates that the product is performing as expected; there is no deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2015-00014 |
| MDR Report Key | 4779033 |
| Report Source | 05 |
| Date Received | 2015-05-18 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-01-09 |
| Date Mfgr Received | 2015-05-20 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-05-19 |
| 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 | 224667-512 |
| 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 |
| Generic Name | CHAGAS |
| Product Code | MIU |
| Date Received | 2015-05-18 |
| Catalog Number | 07K35-68 |
| Lot Number | 39515M500 |
| Device Expiration Date | 2015-03-03 |
| 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 | 2015-05-18 |