MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-15 for VITROS CHEMISTY PRODUCTS AMON SLIDES 1726926 manufactured by Ortho-clinical Diagnostics.
[28735503]
The customer observed higher than expected vitros amon quality control results from vitros liquid performance verifier control fluid using vitros amon micro slides on a vitros 5,1 fs chemistry system. A user error related to the use of expired reagents is the likely assignable cause. In addition, an unidentified instrument issue cannot be ruled out as a contributing factor as the customer would not perform recommended testing to verify instrument performance.
Patient Sequence No: 1, Text Type: N, H10
[28735504]
The customer observed higher than expected vitros amon quality control results from vitros liquid performance verifier control fluid using vitros amon micro slides on a vitros 5,1 fs chemistry system. Level 2 results: 247. 0 and 235. 0 umol/l vs. Expected 194. 2 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected. There were no allegations of patient harm. This report is number one of two mdr's for this event. Two 3500a forms are being submitted for this event as two devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2015-00109 |
| MDR Report Key | 5153652 |
| Date Received | 2015-10-15 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-09-17 |
| Date Mfgr Received | 2015-09-18 |
| Device Manufacturer Date | 2013-09-20 |
| Date Added to Maude | 2015-10-15 |
| 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 | 2015-10-15 |
| Catalog Number | 1726926 |
| Lot Number | 1015-0233-7466 |
| Device Expiration Date | 2015-03-01 |
| 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 | 2015-10-15 |