MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-07 for EBV VCA IGG 25184 manufactured by Quest International, Inc..
[4369914]
On (b)(6) 2014, a customer contacted bio-rad laboratories technical support department concerning a result obtained when running the bio-rad ebv vca igg assay with a microplate reader. The user-defined program for this assay on the microplate reader was incorrectly programmed by the customer to not include the equivocal range result interpretation for 0. 9-1. 1 index as mentioned in the package insert. Due to this error, a patient test result of 0. 948 index which should have resulted in "equivocal" result interpretation resulted in "negative" result interpretation. The customer caught the error and correctly reported this patient result as equivocal. On (b)(6) 2014, the customer reported 12 samples that were incorrectly reported as negative instead of equivocal upon performing a look back of previous runs of this assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022521-2014-00004 |
| MDR Report Key | 3812317 |
| Report Source | 07 |
| Date Received | 2014-05-07 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-02-23 |
| Date Mfgr Received | 2014-02-23 |
| Date Added to Maude | 2014-05-29 |
| 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 | SCOTT DENNIS |
| Manufacturer Street | 6565 185TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981741 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EBV VCA IGG |
| Generic Name | IVD, EIA |
| Product Code | LSE |
| Date Received | 2014-05-07 |
| Catalog Number | 25184 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST INTERNATIONAL, INC. |
| Manufacturer Address | DORAL FL 33122 US 33122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-07 |