MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-30 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 1882208 manufactured by Ortho-clinical Diagnostics.
[109903303]
The investigation determined higher than expected results were obtained on a patient sample and a non-vitros quality control fluid processed using a vitros glucose reagent on a vitros 5600 integrated system. There was no evidence to suggest the vitros glucose reagent or instrument malfunctioned. It was concluded that a sub-optimal calibration event was the most likely assignable cause. The issue began after a new vitros glucose lot was calibrated and put into use. The calibration parameters were reviewed and were concluded to be atypical. The issue was resolved when the vitros glucose lot was re-calibrated using the same calibration kit lot and acceptable quality control performance has been maintained.
Patient Sequence No: 1, Text Type: N, H10
[109903304]
The customer obtained a higher than expected vitros patient result and three higher than expected quality control results processed using vitros glucose on a vitros 5600 integrated system. Non-vitros biorad liquicheck control (lot31842) level 2 glu = 507. 8, 502. 4, 569. 7 versus expected 274. 4 mg/dl. Patient sample = >1250 versus expected 673 mg/dl. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The biased patient result was reported outside of the laboratory. There were no reports treatment was altered, initiated or stopped based on the reported result. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00016 |
| MDR Report Key | 7553084 |
| Date Received | 2018-05-30 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-04-29 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2018-05-30 |
| 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 1 |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | JIX |
| Date Received | 2018-05-30 |
| Catalog Number | 1882208 |
| Lot Number | 0137 |
| ID Number | 10758750000166 |
| Device Expiration Date | 2019-05-01 |
| 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 | 2018-05-30 |