MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-26 for VITROS CLINICAL CHEMISTRY PRODUCTS AMON SLIDES 1721869 manufactured by Ortho-clinical Diagnostics.
[44459139]
The investigation determined higher than expected vitros amon results were obtained from vitros quality control fluids using the vitros amon slides on a vitros 5600 integrated system. An assignable cause was not determined. However, an amon reagent issue, an instrument issue, or a fluid handling issue cannot be ruled out as contributing factors.
Patient Sequence No: 1, Text Type: N, H10
[44459140]
Higher than expected ammonia results were obtained from two levels of vitros quality control fluids when using vitros ammonia (amon) slides on a vitros 5600 integrated system. Vitros lpvi vitros amon results 103. 3, 170. 2, 158. 7, and 166. 2 umol/l versus expected 45 umol/l. Vitros lpvii vitros amon results 237, 310, 293, and 296 umol/l versus expected 176. 9 umol/l. Patient samples were not processed due to the higher than expected control results. However the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report is number two of eight mdr's for this event. Eight 3500a forms are being submitted for this event as eight devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00036 |
| MDR Report Key | 5608971 |
| Date Received | 2016-04-26 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-03-19 |
| Date Mfgr Received | 2016-03-29 |
| Device Manufacturer Date | 2015-07-17 |
| Date Added to Maude | 2016-04-26 |
| 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 CLINICAL CHEMISTRY PRODUCTS AMON SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JID |
| Date Received | 2016-04-26 |
| Catalog Number | 1721869 |
| Lot Number | 1015-0240-5383 |
| Device Expiration Date | 2017-01-01 |
| 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 | 2016-04-26 |