MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for VITROS CHEMISTY PRODUCTS AMON SLIDES 1726926 manufactured by Ortho-clinical Diagnostics.
[32248322]
The investigation determined that higher than expected vitros amon quality control results were obtained from a non-vitros control fluid using vitros amon micro slides on a vitros 5600 integrated system. The definitive assignable cause could not be determined. A reagent issue or a cartridge handling issue could not be ruled out as the issue was isolated to two amon cartridges. In addition, an instrument issue could not be ruled out as a contributing factor based on within run precision testing performance outside of the guideline.
Patient Sequence No: 1, Text Type: N, H10
[32248323]
The customer observed higher than expected vitros amon quality control results from a non-vitros control fluid using vitros amon micro slides on a vitros 5600 integrated system. Amon results: 295. 0, 296. 0, 290. 2, and 295. 0 umol/l vs. Expected 233. 0 umol/l biased results of the direction and magnitude observed may lead to inappropriate physician action. The customer stated that no vitros amon patient samples were processed during the time frame of the event. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report is number four of four mdrs for this event. Four 3500a forms are being submitted for this event as four devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2015-00115 |
| MDR Report Key | 5247220 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-10-26 |
| Date Mfgr Received | 2015-10-30 |
| Device Manufacturer Date | 2015-03-10 |
| Date Added to Maude | 2015-11-24 |
| 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 CHEMISTY PRODUCTS AMON SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JID |
| Date Received | 2015-11-24 |
| Catalog Number | 1726926 |
| Lot Number | 1014-0239-1989 |
| Device Expiration Date | 2016-09-01 |
| 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 | 2015-11-24 |