MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for VITROS CHEMISTY PRODUCTS AMON SLIDES 1726926 manufactured by Ortho-clinical Diagnostics.
[34763107]
The investigation determined that a non-reproducible lower than expected vitros amon quality control result was obtained from one level of a vitros control fluid using vitros amon slides on a vitros 5600 integrated chemistry system. A definitive assignable cause for the event was not identified. As limited information was available, and the customer did not want to continue the investigation, a vitros amon reagent issue and a vitros instrument malfunction cannot be ruled out as contributing factors.
Patient Sequence No: 1, Text Type: N, H10
[34763108]
The customer observed a non-reproducible lower than expected vitros amon quality control result from one level of a non - vitros control fluid using vitros amon slides on a vitros 5600 integrated chemistry system. Vitros amon result: 187. 41 ug/dl vs. Expected 234. 8 ug/dl. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected. There were no allegations of patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2015-00125 |
| MDR Report Key | 5316455 |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-21 |
| Date of Event | 2015-11-27 |
| Date Mfgr Received | 2015-11-25 |
| Device Manufacturer Date | 2014-07-27 |
| Date Added to Maude | 2015-12-21 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 CHEMISTY PRODUCTS AMON SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JID |
| Date Received | 2015-12-21 |
| Catalog Number | 1726926 |
| Lot Number | 1014-0237-5676 |
| Device Expiration Date | 2016-01-01 |
| 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 | 2015-12-21 |