MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for VITROS CHEMISTRY PRODUCTS LAC SLIDES 8433880 manufactured by Ortho-clinical Diagnostics.
[59868872]
The investigation determined that the customer obtained higher and lower than expected vitros lactate quality control (qc) results using the vitros 5600 integrated system. The assignable cause of the event is most likely the use of sub-optimal calibrations that subsequently caused the higher and lower than expected lactate quality control results. The customer obtained multiple sub-optimal calibration parameters when compared to expected parameters using the same vitros lactate lot with three different calibrator kit lots and therefore, it is not likely that the issue was related to the calibrator kit lots themselves. Improper pre-analytical calibrator fluid handling is a likely contributing factor, but this could not be definitively confirmed. A successful recalibration using the same lactate lot was obtained with no changes to the instrument or the lactate reagent. A malfunction of the vitros 5600 integrated systems or a vitros lac reagent lot issue are not likely contributors to this event.
Patient Sequence No: 1, Text Type: N, H10
[59868873]
A customer obtained higher and lower than expected vitros lactate quality control results while using the vitros 5600 integrated system. Vitros l1= 2. 57, 2. 58 vs. Expected 1. 34 mmol/l; vitros l2= 7. 11, 7. 11, 7. 11, 7. 18 vs. Expected 3. 84 mmol/l; biorad l1= 4. 84 vs. Expected 5. 86 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The unexpected vitros lactate results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the event. This report is number three of seven mdr? For this event. Seven 3500a forms are being submitted for this event as seven devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00089 |
| MDR Report Key | 6077397 |
| Date Received | 2016-11-03 |
| Date of Report | 2016-11-03 |
| Date of Event | 2016-10-08 |
| Date Mfgr Received | 2016-10-08 |
| Device Manufacturer Date | 2016-04-17 |
| Date Added to Maude | 2016-11-03 |
| 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 | 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 | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS LAC SLIDES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | KHP |
| Date Received | 2016-11-03 |
| Catalog Number | 8433880 |
| Lot Number | 3531-0091-1618 |
| Device Expiration Date | 2017-10-01 |
| 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 | 2016-11-03 |