MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-07 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1726926 manufactured by Ortho-clinical Diagnostics.
[35802571]
The investigation determined that non-reproducible, lower and higher than expected amon results were obtained from 2 quality control fluids and a patient sample when using a vitros 5,1 chemistry system. The most likely assignable cause for 13 of the results is instrument related. Following maintenance actions by an ortho field engineer, acceptable vitros amon precision testing was observed. User error contributed to a single, higher than expected, quality control result. This result was generated from a cartridge that exceeded the onboard stability time of 1 week noted in the reagent storage and stability section of the vitros amon instructions for use. There was no evidence that a vitros amon reagent issue contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[35802572]
A customer reported non-reproducible, higher and lower than expected amon results obtained using 2 amon reagent lots on 2 quality control fluids and a single patient sample processed using a vitros 5,1 chemistry system. Vitros 5,1 chemistry system, 34000731, amon reagent lot 1015-0238-7393: liquid performance verifier level 1 result = 260 umol/l vs. Expected 29. 5 umol/l. Liquid performance verifier level 2 result = 213. 4, 123. 3, 129. 2, 122. 7, 119. 5, 128. 9, and 226. 0 umol/l vs. Expected 162. 24 umol/l. Patient sample result = 99. 9 umol/l versus estimated expected result of 49. 1 umol/l. Amon reagent lot 1015-0240-5383: liquid performance verifier level 2 result = 102. 7, 136. 0, 108. 8, and 138. 8 umol/l vs. Expected 176. 9 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples. No amon patient results were reported outside of the laboratory. There was no allegation of patient harm. 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. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00001 |
| MDR Report Key | 5350212 |
| Date Received | 2016-01-07 |
| Date of Report | 2016-01-07 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2015-12-09 |
| Device Manufacturer Date | 2014-09-24 |
| Date Added to Maude | 2016-01-07 |
| 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 | 2016-01-07 |
| Catalog Number | 1726926 |
| Lot Number | 1015-0238-7393 |
| Device Expiration Date | 2016-03-01 |
| 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 | 2016-01-07 |