MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-13 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[67486267]
The investigation determined that higher than expected vitros na+ results were obtained from vitros performance verifiers in combination with a vitros 5600 integrated system. The likely cause of the higher than expected vitros na+ results is a suboptimal calibration from 28 january 2017. User error in the reconstitution of calibrator fluids is the likely cause of the suboptimal calibration. Acceptable vitros na+ quality control results were obtained after calibrating vitros na+ slides with properly prepared calibrator fluids. There is no evidence that a vitros 5600 system malfunctioned. Acceptable vitros na+ results were obtained from vitros na+ reagent lot 4205-0960-6557 before the 28 january 2017 calibration and after the 30 january 2017 calibration; therefore a vitros na+ reagent issue can be ruled out as the cause of the higher than expected results.
Patient Sequence No: 1, Text Type: N, H10
[67486268]
A customer observed higher than expected vitros sodium (na+) results from vitros performance verifiers (pv) in combination with a vitros 5600 integrated system. Pv1 vitros na+ result 181. 2 mmol/l versus expected na result 122. 7 mmol/l, pv2 vitros na+ result 186. 6 mmol/l versus expected na result 142. 0 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected. The higher than expected vitros na+ results were generated from control fluids and no patient samples were tested, however, the investigation could not rule out that patient samples would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00004 |
| MDR Report Key | 6325245 |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-01-28 |
| Date Mfgr Received | 2017-01-28 |
| Device Manufacturer Date | 2016-07-18 |
| Date Added to Maude | 2017-02-13 |
| 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 DIAGNOSTIC |
| Product Code | JIX |
| Date Received | 2017-02-13 |
| Catalog Number | 1662659 |
| Lot Number | 226 |
| 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 | 2017-02-13 |