MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-08-20 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[16496916]
Investigation into this event found no evidence that the vitros eci did not operate as expected. The investigation determined that the samples used for the vitros myog correlation study were frozen aliquots that had been thawed three times during the timeframe of the event. The vitros myog instructions for use state: "serum samples may be stored for up to 7 days at 2-8 degrees celsius (36-46 degrees fahrenheit) or 4 weeks at -20 degrees celsius (-4 degrees fahrenheit). Avoid repeated freeze-thaw cycles of serum samples. " the definitive root cause could not be determined, however, user error in handling of the pt samples used for the correlation could not be ruled out.
Patient Sequence No: 1, Text Type: N, H10
[16704693]
The ocd lab specialist reported that negatively biased vitros myog results were obtained on two pt samples processed on a vitros eci during a correlation study on (b)(6) and (b)(6) 2009. Biased results of the direction and magnitude observed could lead to inappropriate physician action. The results were not reported as they were only being used for the correlation. There was no report of pt harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680658-2009-00240 |
| MDR Report Key | 1487553 |
| Report Source | 07 |
| Date Received | 2009-08-20 |
| Date of Report | 2009-07-23 |
| Date of Event | 2009-07-23 |
| Date Mfgr Received | 2009-07-23 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-06-14 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOE FALVO |
| Manufacturer Street | 100 INDIGO CREEK DR. |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| Manufacturer G1 | FOREST FARM ESTATE |
| Manufacturer City | WHITCHURCH CARDIFF CF147YT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF14 7YT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2009-08-20 |
| Model Number | NA |
| Catalog Number | 6801042 |
| Lot Number | 0590 |
| ID Number | NA |
| Device Expiration Date | 2009-11-02 |
| 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 DR. ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-20 |