MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-04 for VITROS CHEMISTRY PRODUCTS LACTATE SLIDES 8150112 manufactured by Ortho-clinical Diagnostics.
[141506944]
The investigation determined that higher than expected vitros lac results were obtained from two different levels of non-vitros biorad multiqual unassayed control lot 47970, tested with vitros lac slide lot 3530-0103-5136 on a vitros 5600 integrated system. The investigation could not determine an assignable cause. The event suddenly occurred on 18 january 2019. Both acceptable and unacceptable vitros lac quality control results were obtained from two different affected cartridges, indicating the vitros lac slides in use did not likely contribute to the event. In addition, acceptable quality control results were obtained for 8 days prior to the event, using the same calibration event, indicating the event was not calibration driven. Acceptable quality control results were obtained after the event occurred, through the present, with no actions taken to improve performance. This indicates that vitros lac slide lot 3530-0103-5136 was performing as intended on the vitros 5600 integrated system since the event that occurred on (b)(6) 2019. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros lac slide lot 3530-0103-5136.
Patient Sequence No: 1, Text Type: N, H10
[141506945]
A customer reported higher than expected quality control (qc) results obtained using vitros chemistry products lactate (lac) slides on a vitros 5600 integrated system. Non-vitros biorad quality control lot 47970. L1 vitros lac result of 2. 10 mmol/l vs. The expected result of 1. 43 mmol/l. L2 vitros lac results of 4. 43, 4. 44, and 4. 41 mmol/l vs. The expected result of 3. 49 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 lac results were generated from non-patient fluids and the customer made no indication that patient samples were affected. There was no allegation of patient harm as a result of the event. This report is number 3 of 4 mdr? S for this event. Four (4) 3500a forms are being submitted for this event as 4 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4) / ivd (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2019-00011 |
| MDR Report Key | 8387355 |
| Date Received | 2019-03-04 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2018-11-30 |
| Date Added to Maude | 2019-03-04 |
| 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 LACTATE SLIDES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | KHP |
| Date Received | 2019-03-04 |
| Catalog Number | 8150112 |
| Lot Number | 3530-0103-5136 |
| 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 | 2019-03-04 |