MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-08 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[74896387]
The investigation determined that lower and higher than expected vitros na+ results were obtained from quality control samples when processed on two vitros 5600 integrated systems. The most likely assignable cause for the event is user error related to improper pre-analytical calibrator fluid preparation. There was no evidence to suggest that the vitros na+ reagent or the vitros 5600 integrated systems malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[74896388]
A customer obtained lower and higher than expected vitros na+ results from quality control samples when processed on two vitros 5600 integrated systems. The following results breached vitros na+ potential health and safety criteria: (b)(6). Biased results of the direction and magnitude observed could lead to inappropriate physician action if the event were to occur with patient samples. There were no unexpected patient sample results reported outside the laboratory and no allegation of patient harm due to this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00007 |
| MDR Report Key | 6551355 |
| Date Received | 2017-05-08 |
| Date of Report | 2017-05-08 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2016-07-18 |
| Date Added to Maude | 2017-05-08 |
| 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 | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | JIX |
| Date Received | 2017-05-08 |
| Catalog Number | 1662659 |
| Lot Number | 0226 |
| ID Number | 10758750009503 |
| Device Expiration Date | 2018-07-18 |
| 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 | 2017-05-08 |