MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2014-08-14 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[4956172]
The customer obtained lower than expected vitros dgxn quality control results (mas level 3= 0. 48, <0. 4, 0. 47, <0. 4, <0. 4, <0. 4, 0. 53 vs. Expected 2. 0 ng/ml) processed on a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No patient samples were known to have been affected or reported from the laboratory. There was no allegation of patient harm as a result of this event. This report is number two of seven mdr? S for this event. Seven 3500a forms are being submitted for this event as seven devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11986282]
The investigation determined that lower than expected vitros dgxn quality control results were obtained on a vitros 5600 integrated chemistry system. There was no indication that an instrument issue contributed to the event. The investigation could not determine an assignable cause. A vitros dgxn reagent issue, improper pre-analytical fluid handling protocol or the mas control fluids in use cannot be ruled out as contributing factors to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2014-00032 |
| MDR Report Key | 4010225 |
| Report Source | 00,01,05 |
| Date Received | 2014-08-14 |
| Date of Report | 2014-08-14 |
| Date of Event | 2014-07-09 |
| Date Mfgr Received | 2014-07-16 |
| Device Manufacturer Date | 2014-02-27 |
| Date Added to Maude | 2014-08-28 |
| 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. 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS DGXN SLIDES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | KXT |
| Date Received | 2014-08-14 |
| Catalog Number | 8343386 |
| Lot Number | 1904-0220-1743 |
| Device Expiration Date | 2014-08-15 |
| 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 | 2014-08-14 |