MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-07 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12 6801697 manufactured by Ortho-clinical Diagnostics.
[18975025]
A customer observed multiple, higher than expected vitros valp calibrator fluid results (cal level 4 results = 47. 95, 49. 98 - g/ml vs. 38. 2 - g/ml; cal level 5 results = 106. 65, 108. 42 - g/ml vs. 83. 3 - g/ml; cal level 6 results = 153. 2, 155. 0 - g/ml vs. 126. 3 - g/ml) while using the vitros 5600 integrated system. Biased results of the direction and magnitude observed may lead to inappropriate physician action if the event were to recur undetected with a patient sample. No patient samples were known to be affected. There was no allegation of harm to patients as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19118499]
The investigation determined that multiple, higher than expected vitros valp calibrator fluid results were obtained. Patient results were not known to have been affected. A definitive root cause could not be determined. However, the in-use calibrator kit and/or an improper pre-analytical calibrator fluid handling issue cannot be ruled out as contributing factors. Once the system was calibrated with an alternate calibrator kit lot, expected results were obtained. There is no evidence that the vitros 5600 system or vitros valp reagent malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2011-00042 |
| MDR Report Key | 2362386 |
| Report Source | 05 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-12-07 |
| Date of Event | 2011-11-10 |
| Date Mfgr Received | 2011-11-10 |
| Device Manufacturer Date | 2011-06-30 |
| Date Added to Maude | 2012-07-23 |
| 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 CHEMISTRY PRODUCTS CALIBRATOR KIT 12 |
| Generic Name | IN-VITRO DIAGNOSTIC CALIBRATOR |
| Product Code | DLJ |
| Date Received | 2011-12-07 |
| Catalog Number | 6801697 |
| Lot Number | 1201 |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-12-07 |