MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT 6801989 manufactured by Ortho-clinical Diagnostics.
[79912142]
The investigation determined that a false negative vitros benz result (<85 ng/ml) was obtained from a patient sample based on confirmatory testing using a non-vitros method, hdlc/ms and chemiluminescence, when tested on a vitros 5600 integrated system. The most likely cause is a known limitation of the vitros benz reagent related to low cross reactivity with lorazepam glucuronide. There is no evidence to suggest that the vitros benz reagent lot 1523-30-5303 malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[79912143]
A customer obtained an unexpected discordant vitros benz negative result using a <200 ng/ml cutoff from a urine sample from a patient suspected of accidentally ingesting lorazepam when the physician expected a positive result from the patient due to their condition, on a vitros 5600 integrated system. Patient 1 vitros result < 85 ng/ml (negative) versus an expected positive result (>200 ng/ml). Biased results of the magnitude and direction observed may lead to inappropriate physician action. The discordant vitros benz result was reported out of the laboratory. However, there was no report of treatment started, stopped, or altered based on the false negative vitros benz result and there was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00011 |
| MDR Report Key | 6692692 |
| Date Received | 2017-07-07 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-06-04 |
| Date Mfgr Received | 2017-06-13 |
| Device Manufacturer Date | 2017-04-18 |
| Date Added to Maude | 2017-07-07 |
| 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 BENZ REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JXM |
| Date Received | 2017-07-07 |
| Catalog Number | 6801989 |
| Lot Number | 1523-30-5303 |
| ID Number | 10758750001750 |
| Device Expiration Date | 2017-07-18 |
| 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 | 2017-07-07 |