MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-05 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[3839822]
The customer reports a falsely reactive prism chagas assay result on one donor sample. The sample generated an initial reactive result of 2. 65 s/co with repeat reactive results of 2. 13 and 1. 60 s/co. The sample tested negative by ripa confirmation testing. The customer noted that their initial reactive (. 032%) and repeat reactive rates (0. 23%) for (b)(6) 2013 exceeded assay package insert claims of 0. 28% and 0. 22% respectively. The customer noted that there were no changes in their testing process. The majority of samples were fresh serum with possibly a few fresh plasma samples. All donors were being tested for the first time for chagas. The customer stated that the current and previous reagent lots have had no issues and are performing as expected. No suspect results had been reported from the lab with no donor impact.
Patient Sequence No: 1, Text Type: D, B5
[10923308]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[26492915]
The evaluation of complaint data for the prism chagas assay lot 23242m501 did not identify any atypical activity. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. A review of the lot device history records did not reveal any issues related to the observations made by the customer. Also, a review of the prism metrics field data indicates that lot 23242m501 (including base lot) is meeting labeling claims for clinical specificity. No performance issues were identified. The prism chagas assay package insert contains information to address the current customer issue. Based on the results of the current evaluation, a product malfunction was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00335 |
| MDR Report Key | 3327939 |
| Report Source | 05 |
| Date Received | 2013-09-05 |
| Date of Report | 2013-08-20 |
| Date of Event | 2013-07-27 |
| Date Mfgr Received | 2013-09-30 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-12-04 |
| 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 | 2013-09-05 |
| Catalog Number | 07K35-68 |
| Lot Number | 23242M501 |
| Device Expiration Date | 2013-09-27 |
| Operator | OTHER |
| 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 | 2013-09-05 |