MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-27 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[3957585]
The customer stated a prism analyzer generated false repeat reactive chagas results for five patient samples. Individual patient data was not provided. The samples were confirmed to be negative using ripa confirmation. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[11068601]
(b)(4). A follow up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[11281322]
Further investigation of the customer issue included a review of the complaint text, specificity testing, a search for similar complaints, and a review of labeling. Additional patient data was provided: (b)(4) initially reactive 1. 66 s/co, repeated reactive on the same instrument 1. 21 and 1. 35 s/co (b)(4) initially reactive 1. 05 s/co, repeated 1. 10 s/co (reactive) and 0. 79 s/co (non-reactive) (b)(4) initially reactive 1. 63 s/co, repeated reactive 1. 47 and 1. 69 s/co (b)(4) initially reactive 4. 55 s/co, repeated reactive 5. 14 and 4. 42 s/co (b)(4) initially reactive 6. 07 s/co, repeated reactive 6. 80 and 5. 43 s/co analysis of field data for chagas reagent lot 23242m501 and base lot 23242m500 showed the lots are meeting specificity claims. Tracking and trending did not identify atypical activity for the chagas reagent lot. Labeling was reviewed and found to be adequate. A product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00329 |
| MDR Report Key | 3311528 |
| Report Source | 05 |
| Date Received | 2013-08-27 |
| Date of Report | 2013-08-20 |
| Date of Event | 2013-07-31 |
| Date Mfgr Received | 2013-10-02 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-11-25 |
| 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 | 2013-08-27 |
| Catalog Number | 07K35-68 |
| Lot Number | 23242M501 |
| Device Expiration Date | 2013-09-27 |
| 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 | 2013-08-27 |