PAN ENTERO BLEND * 3360

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-07 for PAN ENTERO BLEND * 3360 manufactured by *.

Event Text Entries

[16147186] The pt's heart biopsy specimen was sent for viral culture. It was noted to be positive for virus eleven days later. (cmv was already ruled out). It was stained with the pan-enterovirus blend reagent, mfg by chemicon int'l, which appeared strongly positive. The result was reported to the physician. Later, upon review of the work-up of this culture, it was noted that all 3 passage tubes were positive for virus. This did not fit with an enterovirus result. Further work with the virus revealed a herpes simplex virus type 1. This was determined on 5/2002. The pt had subsequently been taking a drug for enterovirus, based on the first result. The technical svc for chemicon was called on 5/2002, where they informed rptr that they had one of two bad lot numbers that could give a false positive. They said they had determined that the reagent had too high of a titer of the antibody. Had received no notification that their reagent was one of the bad lot numbers (lot # 21110399). Not until 6/2002 was an urgent notice sent with new reagent to say rptr's reagent was giving "higher than expected background reactivity on certain samples".
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1025252
• MDR Report Key: 398597
• Date Received: 2002-06-07
• Date of Report: 2002-06-07
• Date of Event: 2002-05-13
• Date Added to Maude: 2002-06-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: MEDICAL TECHNOLOGIST
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PAN ENTERO BLEND
• Generic Name: *
• Product Code: JSC
• Date Received: 2002-06-07
• Model Number: *
• Catalog Number: 3360
• Lot Number: 21110399
• ID Number: *
• Device Expiration Date: 2003-04-01
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 387641
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-06-07