MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2010-07-16 for VITROS MALB REAGENT 6801740 manufactured by Ortho-clinical Diagnostics.
[1593655]
This customer obtained lower than expected vitros malb results for three patient samples while using the vitros 5,1 fs chemistry system. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The original results were reported to the clinician. There were no allegations of harm to the patients as a result of these events. This report is number one of three mdrs for this event. Three 3500a forms are being submitted for this event as three devices (three reported false negative results from the customer) were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4)
Patient Sequence No: 1, Text Type: D, B5
[8563282]
The investigation confirmed that lower than expected vitros malb patient results were obtained while using the vitros 5,1 fs analyzer. A definitive root cause has not be determined. However, an antigen excess effect in the presence of elevated albumin levels in the patient samples cannot be ruled out. The investigation into vitros malb reagent performance is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2010-00012 |
| MDR Report Key | 1759948 |
| Report Source | 00,01,05 |
| Date Received | 2010-07-16 |
| Date of Report | 2010-07-16 |
| Date of Event | 2010-01-28 |
| Date Mfgr Received | 2010-06-18 |
| Device Manufacturer Date | 2009-11-13 |
| Date Added to Maude | 2011-04-18 |
| 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 | MR. JOSEPH FALVO |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS MALB REAGENT |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | CIX |
| Date Received | 2010-07-16 |
| Catalog Number | 6801740 |
| Lot Number | 1505-04-9484 |
| Device Expiration Date | 2011-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-16 |