MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1721869 manufactured by Ortho-clinical Diagnostics.
[126371223]
The investigation concluded that higher than expected vitros clinical chemistry products ammonia (amon) results were obtained from cap general chemistry quality cross check samples using vitros amon slides lot 1018-0249-9308 on a vitros 5600 integrated system. The investigation could not confirm the assignable cause of the event. The quality control results were within 1 to 2 sd of the biorad peer group mean after the initial calibration as well as on the day the cap fluids were processed. Additionally, the within run vitros amon precision test was within ortho guidelines indicating the vitros 5600 is performing as expected. There is no evidence to suggest vitros amon slides lot 1018-0249-9308 or the vitros 5600 system are not performing as expected. Furthermore, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with vitros amon slides lot 1018-0249-9308. Additional information regarding the handling of the cap fluids was not provided. An issue with the samples is the suspected cause of the event, however, a fluid handling issue or an issue related to the samples could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[126371224]
A customer reported higher than expected vitros clinical chemistry products ammonia (amon) results obtained from (b)(6) general chemistry quality cross check samples using vitros amon slides lot 1018-0249-9308 on a vitros 5600 integrated system. Czq-a 02 vitros amon result 709 umol/l versus expected vitros amon result 574. 8 umol/l, czq-a 03 vitros amon result 444 umol/l versus expected vitros amon result 369. 2 umol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected vitros amon results were obtained when processing cap fluids. There were no allegations of patient harm as a result of this event. This report is number 2 of 2 mdr? S for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00115 |
| MDR Report Key | 7999005 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-09-28 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2018-04-22 |
| Date Added to Maude | 2018-10-24 |
| 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 DIAGNOSTICS |
| Product Code | JID |
| Date Received | 2018-10-24 |
| Catalog Number | 1721869 |
| Lot Number | 1018-0249-9308 |
| Device Expiration Date | 2019-10-01 |
| 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 | 2018-10-24 |