MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-08 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[3846352]
A customer observed multiple reproducible, lower than expected vitros gent quality control results on a single level of quality control fluid (biorad level 3 = 5. 07, 3. 53, 4. 65, 5. 47 and 5. 38 ug/ml vs. An expected result of 8. 02 ug/ml) on a vitros 5600 integrated system. 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 is number one of three mdr? S for this event. Three 3500a forms are being submitted for this event as three devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11212535]
The investigation determined that multiple reproducible, lower than expected vitros gent quality control results were obtained on a vitros 5600 integrated system. The investigation was unable to determine a definitive root cause. However, an instrument or reagent related issue, the biorad quality control fluids in use at the time of the event, or improper reagent or control fluid handling protocol cannot be ruled out as potential contributing factors. Expected quality control results were obtained following ocd field service and following ocd and biorad recommended reagent and fluid handling protocols. The customer and ocd are continuing to monitor vitros gent performance. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2013-00048 |
| MDR Report Key | 3457718 |
| Report Source | 05 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-11-08 |
| Date of Event | 2013-10-10 |
| Date Mfgr Received | 2013-10-10 |
| Device Manufacturer Date | 2012-05-29 |
| Date Added to Maude | 2014-02-06 |
| 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 | 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 GENT REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LCD |
| Date Received | 2013-11-08 |
| Catalog Number | 6801711 |
| Lot Number | 1512-08-2210 |
| Device Expiration Date | 2014-02-28 |
| 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 | 2013-11-08 |