MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2004-02-20 for VITROS CHEMISTRY PRODUCTS LITHIUM SLIDES 1632660 manufactured by Ortho-clinical Diagnostics.
[335616]
The customer obtained biased pt results for lithium slides following failed quality control results. Correct results were obtained upon retesting qc and pt sample with a fresh lithium slide cartridge. Biased results of this type may initiate inappropriate physician action. No results reported and there was no report of pt harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1319681-2004-00030 |
MDR Report Key | 525541 |
Report Source | 01,05 |
Date Received | 2004-02-20 |
Date of Report | 2004-01-10 |
Date of Event | 2004-01-10 |
Date Mfgr Received | 2004-01-10 |
Device Manufacturer Date | 2003-06-01 |
Date Added to Maude | 2004-05-20 |
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 | 3 |
Event Location | 0 |
Manufacturer Contact | THOMAS SMITH |
Manufacturer Street | 100 INDIGO CREEK DRIVE |
Manufacturer City | ROCHESTER NY 146265101 |
Manufacturer Country | US |
Manufacturer Postal | 146265101 |
Manufacturer Phone | 5854533735 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VITROS CHEMISTRY PRODUCTS LITHIUM SLIDES |
Generic Name | IN VITRO DIAGNOSTIC |
Product Code | JII |
Date Received | 2004-02-20 |
Model Number | NA |
Catalog Number | 1632660 |
Lot Number | 3111-0054-2970 |
ID Number | NA |
Device Expiration Date | 2005-03-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 514676 |
Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
Manufacturer Address | 100 INDIGO CREEK DR. ROCHESTER NY 146265101 US |
Baseline Brand Name | VITROS CHEMISTRY PRODUCTS LITHIUM SLIDES |
Baseline Generic Name | IN VITRO DIAGNOSTIC |
Baseline Model No | NA |
Baseline Catalog No | 1632660 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2004-02-20 |