MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1726926 manufactured by Ortho-clinical Diagnostics.
[141465269]
The investigation determined that a higher than expected vitros ammonia (amon) result was obtained from a single patient sample tested on a vitros 250 chemistry system. The result was higher than expected when compared to the vitros amon result obtained from an alternate sample collected from the same patient, tested on the same vitros 250 chemistry system. The assignable cause of the event is most likely due to improper pre-analytical sample storage of patient sample 1. Patient sample 1 was stored at room temperature for 30 minutes prior to testing. In addition, it is unknown if the plasma was separated from the cellular material within 15 minutes of collection. The vitros amon ifu states that room temperature storage is not recommended. Ammonia is a time sensitive assay due to increase in ammonia concentration as the sample ages. There was no indication the vitros 250 system malfunctioned. Vitros amon precision testing performed was within acceptable guidelines, suggesting an instrument issue was not likely a contributing factor. Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon slide lot 1018-0249-9334. No historical quality control results were provided, therefore, an unexpected performance issue with vitros amon slide lot 1018-0249-9334 cannot be ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[141465270]
A customer obtained a higher than expected vitros ammonia (amon) result from a single patient sample tested on a vitros 250 chemistry system. The result was higher than expected when compared to the vitros amon result obtained from an alternate sample collected from the same patient, tested on the same vitros 250 chemistry system. Patient sample 1 vitros amon result of 725 umol/l vs. The patient sample 2 vitros amon result of 24 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The higher than expected vitros amon result was reported outside the laboratory, but there was no allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2019-00013 |
| MDR Report Key | 8390257 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-02-07 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2019-03-05 |
| 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 | 2019-03-05 |
| Catalog Number | 1726926 |
| Lot Number | 1018-0249-9334 |
| 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 | 2019-03-05 |