MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-08 for VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES 1314343 manufactured by Ortho-clinical Diagnostics, Inc..
[971073]
A customer observed negatively biased proficiency results using vitros sali slides on a vitros 5,1 fs chemistry system. Biased results of the direction and magnitude observed on a pt specimen may lead to inappropriate physician action. No pt results were affected and there were no allegations of pt harm as a result of this event. Note: this form 3500a is two of five mdrs for this event. Five devices were involved. Five proficiency samples were assayed using a single sali slide lot. This report corresponds to ortho clinical diagnostics inc. (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[8215271]
The investigation determined that the negatively biased sali proficiency results were isolated to the last five slides in one vitros sali slide cart. The root cause could not be determined but may be related to user error when handling the sali slide cart in question. A new slide from the same sali slide lot and from an alternate sali slide lot produced acceptable proficiency results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2008-00301 |
| MDR Report Key | 1202457 |
| Report Source | 05 |
| Date Received | 2008-10-08 |
| Date of Report | 2008-09-12 |
| Date of Event | 2008-09-11 |
| Date Mfgr Received | 2008-09-12 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2010-04-19 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOE FALVO |
| Manufacturer Street | 100 INDIGO CREEK BLVD. |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| 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 | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DKJ |
| Date Received | 2008-10-08 |
| Model Number | NA |
| Catalog Number | 1314343 |
| Lot Number | 2229-0052-6491 |
| ID Number | NA |
| Device Expiration Date | 2009-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-08 |