MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1726926 manufactured by Ortho-clinical Diagnostics.
[116913283]
The investigation determined that imprecise, lower than expected vitros amon results were obtained from a vitros liquid performance verifier (lot c5707) using vitros amon slides (lot 1017-0247-4591) when tested on a vitros 5,1 fs chemistry system. The definitive assignable cause could not be determined. The likely cause of the imprecise, lower than expected vitros amon results is an analyzer related issue caused by microslide incubator contamination. However, without unacceptable amon precision test results prior to the customer cleaning the microslide incubator this could not be confirmed. Historical quality control results were not available to evaluate vitros amon lot 1017-0247-4591 performance. Therefore an issue with vitros amon lot 1017-0247-4591 could not be confirmed or ruled out as a contributor of the event. Additionally, ongoing tracking and trending has not identified signals that indicate an issue with vitros chemistry products amon slides lot 1017-0247-4591. The assignable cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[116913284]
A customer obtained imprecise, lower than expected vitros ammonia (amon) results from a vitros liquid performance verifier using vitros amon slides (lot 1017-0247-4591) when tested on a vitros 5,1 fs chemistry system. Vitros liquid performance verifier ii lot c5707 - vitros amon results 114. 34 and 142. 17 umol/l versus midpoint of rom 194. 5 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Ortho was not made aware of any allegation of patient harm as a result of this event. However the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of actual patient harm as a result of this event. This report is number two of two mdr? S for this event. Two 3500a forms are being submitted for this event as two devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00102 |
| MDR Report Key | 7756170 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-07-10 |
| Date Mfgr Received | 2018-07-11 |
| Device Manufacturer Date | 2017-10-10 |
| Date Added to Maude | 2018-08-07 |
| 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 | 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 | 2018-08-07 |
| Catalog Number | 1726926 |
| Lot Number | 1017-0247-4591 |
| Device Expiration Date | 2019-04-01 |
| 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 | 2018-08-07 |