MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-02 for VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.
[89694526]
The customer obtained a lower than expected result on a single patient sample using vitros vanc reagent lot 2514-36-6074 on a vitros 5600 integrated system. A definitive assignable cause for the event was not identified. The integrity of the patient sample and a reagent issue cannot be completely ruled out as a contributing factor. As a marker precision run has met expectations, a vitros instrument is not considered a contributing factor. The definitive assignable cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
[89694527]
The customer obtained a lower than expected result on a single patient sample using vitros vanc reagent lot 2514-36-6074 on a vitros 5600 integrated system. Patient vitros vanc result of 9. 6 ug/ml vs. The expected result of 16 ug/ml. Biased results of the direction and magnitude observed could lead to inappropriate physician action. The higher than expected vitros vanc patient sample result was not reported from the laboratory and no other vitros vanc patient results were questioned. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00017 |
| MDR Report Key | 6909334 |
| Date Received | 2017-10-02 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-09-05 |
| Device Manufacturer Date | 2017-06-05 |
| Date Added to Maude | 2017-10-02 |
| 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 VANC REAGENT |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LEH |
| Date Received | 2017-10-02 |
| Catalog Number | 6801709 |
| Lot Number | 2514-36-6074 |
| ID Number | 10758750006731 |
| Device Expiration Date | 2018-05-05 |
| 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 | 2017-10-02 |