MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-20 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[131910445]
The investigation determined that lower than expected vitros sodium (na+) results were obtained from a single non-vitros biorad level 3 quality control (qc) fluid, lot 45800, using vitros na+ slides on a vitros 5600 integrated system. The event was isolated to the calibration event performed on (b)(6) 2018. The most likely cause of the suboptimal (b)(6) 2018 calibrations was user error, where improper reconstitution of calibrators occurred. The customer visually observed the reconstituted calibrator vials and stated the volumes were not consistent, vial to vial. In addition, the customer used a cura socorex 3 ml pipette, which uses disposable pipette tips. The customer stated it is possible the tips used to reconstitute the (b)(6) 2018 calibrator fluids were not secured properly onto the cura pipette, which could lead to an improper volume of diluent being added to the lyophilate. Acceptable vitros na+ performance was observed after a calibration event was performed using properly handled calibrator fluids. The investigation found no indication the vitros 5600 integrated system or vitros na+ slide lot 4220-1001-4323 contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[131910446]
A customer obtained lower than expected vitros sodium (na+) results from a single non-vitros biorad level 3 quality control (qc) fluid, lot 45800, using vitros na+ slides on a vitros 5600 integrated system. Biorad l3 na+ results of 133. 2 and 131. 7 mmol/l vs. The expected result of 165. 0 mmol/l biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected vitros na+ results were generated from a non-patient fluid, 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 actual patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00049 |
| MDR Report Key | 8185586 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2018-07-19 |
| Date Added to Maude | 2018-12-20 |
| 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 | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JIX |
| Date Received | 2018-12-20 |
| Catalog Number | 1662659 |
| Lot Number | 0288 |
| 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 | 2018-12-20 |