MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-24 for IMMUNOCARD * 712050 manufactured by Meridian Bioscience, Inc.
[1673261]
When performing patient testing using immunocard toxin a& b, the wash reagent would not absorb into the reaction ports and therefore the testing could not be completed. Testing was attempted using a card from a second box with the same lot number. The same issue occurred. Quality control tests using cards from that lot performed satisfactorily. ====================== health professional's impression======================the wash reagent would not absorb into the reaction ports on the test card. ====================== manufacturer response for immuno toxin a&b test card, immunocard======================the company sent 3 replacement kits overnight and asked to have the defective kits sent back to them. ======================the reporter indicated that all the boxes involved in this event were the same lot number. They "sent the patient testing to a reference lab for completion. " the new kit has different lot numbers and worked satisfactorily. There was no observable manufacturing problems and the manufacturer did not give them an explanation as to why this happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1913122 |
| MDR Report Key | 1913122 |
| Date Received | 2010-11-24 |
| Date of Report | 2010-11-23 |
| Date of Event | 2010-11-03 |
| Report Date | 2010-11-23 |
| Date Reported to FDA | 2010-11-24 |
| Date Added to Maude | 2010-12-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMUNOCARD |
| Generic Name | IMMUNO TOXIN A&B TEST CARD |
| Product Code | LLH |
| Date Received | 2010-11-24 |
| Returned To Mfg | 2010-11-04 |
| Model Number | * |
| Catalog Number | 712050 |
| Lot Number | 7859.274 |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIDIAN BIOSCIENCE, INC |
| Manufacturer Address | 3471 RIVER HILLS DRIVE CINCINNATI OH 45244 US 45244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-24 |