MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1726926 manufactured by Ortho-clinical Diagnostics.
[25143973]
The investigation determined that an unexpected, nonreproducible vitros amon result was obtained from a single patient sample processed using vitros amon slides on a vitros 250 chemistry system. The assignable cause for the event could not be determined with the information available, however the possibility that an unexpected vitros amon reagent performance, pre-analytical handling issue or an unexpected vitros 250 system issue had contributed to the result could not be ruled out.
Patient Sequence No: 1, Text Type: N, H10
[25143974]
The customer complained that an unexpected, nonreproducible vitros amon result was obtained from a single patient sample processed using vitros amon slides on a vitros 250 chemistry system. Vitros amon result: 132 vs expected 88 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The technical solution center was unable to determine what amon result, if any, was reported out of the laboratory for the affected patient. 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 | 1319809-2015-00101 |
| MDR Report Key | 5019464 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-07-24 |
| Device Manufacturer Date | 2014-09-28 |
| Date Added to Maude | 2015-08-20 |
| 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 | 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 | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS AMON SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JID |
| Date Received | 2015-08-20 |
| Catalog Number | 1726926 |
| Lot Number | 1015-0238-7392 |
| Device Expiration Date | 2016-03-01 |
| 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 | 2015-08-20 |