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 2015-03-09 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[21451872]
A customer observed lower than expected dgxn quality control results from omnicore qc fluids when using vitros chemistry products dgxn slides on a vitros 5600 integrated system. Omnicore l2: dgxn result 0. 55 ng/ml vs. Expected result 1. 68 ng/ml. Omnicore l3: dgxn results 0. 58, 0. 47, <0. 4, <0. 4, 0. 51 ng/ml vs. Expected result 2. 00 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action. No patient samples were processed on this analyzer; however, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report is number one of six mdr? S for this event. Six 3500a forms are being submitted for this event as six devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21685663]
The investigation confirmed that lower than expected dgxn quality control results were obtained from omnicore qc fluids when using vitros chemistry products dgxn slides on a vitros 5600 integrated system. The investigation was unable to determine a definitive assignable cause. The omnicore quality control fluids could not be ruled out as a contributing factor. The investigation found no evidence to suggest unexpected vitros dgxn slide or vitros 5600 instrument performance contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2015-00006 |
| MDR Report Key | 4583131 |
| Report Source | 00,01,05 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-03-09 |
| Date of Event | 2015-02-11 |
| Date Mfgr Received | 2015-02-11 |
| Device Manufacturer Date | 2014-11-02 |
| Date Added to Maude | 2015-04-08 |
| 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 DIAGNOSTIC |
| Product Code | LFM |
| Date Received | 2015-03-09 |
| Catalog Number | 8343386 |
| Lot Number | 1906-0227-8610 |
| Device Expiration Date | 2015-04-01 |
| 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 | 2015-03-09 |