MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-25 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[109764276]
The investigation determined that lower than expected gent results were obtained when processing cap fluids on a vitros 4600 chemistry system. The investigation was unable to determine a definitive assignable cause. Historical vitros gent quality control results indicate that vitros gent lot 1512-10-5381 in combination with vitros 4600 system was performing as expected at the time of the event. However, a transient instrument or reagent related issue at the time of the event, or improper pre-analytical sample handling of the cap fluids cannot be ruled out as potential contributing factors.
Patient Sequence No: 1, Text Type: N, H10
[109764277]
A customer observed lower than expected vitros gent results on three different levels of college of american pathologists (cap) proficiency fluids on a vitros 4600 chemistry system. Cap sample chm-02 vitros gent result 3. 2 ug/ml versus expected gent result (cap mean) 4. 93 ug/ml. Cap sample chm-03 vitros gent result 5. 8 ug/ml versus expected gent result (cap mean) 11. 57 ug/ml. Cap sample chm-05 vitros gent result 3. 4 ug/ml versus expected gent result (cap mean) 4. 96 ug/ml. The customer made no allegations that patient sample results were affected. However, biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected. There was no allegation of patient harm. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00015 |
| MDR Report Key | 7546375 |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-05-01 |
| Device Manufacturer Date | 2016-06-03 |
| Date Added to Maude | 2018-05-25 |
| 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 | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| 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 | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS GENT REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LCD |
| Date Received | 2018-05-25 |
| Catalog Number | 6801711 |
| Lot Number | 1512-10-5381 |
| ID Number | 10758750006755 |
| Device Expiration Date | 2018-06-03 |
| 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 | 2018-05-25 |