MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-17 for VITROS CHEMISTRY PRODUCTS LAC SLIDES 8433880 manufactured by Ortho-clinical Diagnostics.
[60752581]
The investigation determined that higher and lower than expected vitros lac quality control results were obtained from vitros control fluids using two different lots of vitros lac slides on a vitros 350 chemistry system. A definitive assignable cause could not be determined. There is no evidence that a vitros 350 system occurred. The unacceptable historical vitros lac quality control results obtained from the customer indicate that the vitros lac lot 3530-0092-3271 was not performing as intended. However, it is suspected that the customer is not following correct protocol when reconstituting the calibrator and control fluids but could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[60752582]
The customer observed higher and lower than expected vitros lac quality control results from vitros control fluids using two different lots of vitros lac slides on a vitros 350 chemistry system. Vitros lac lot 3530-0092-3271: pv2 lot k4852 vitros lac result 2. 58*, 2. 64*, 2. 61*, 2. 62*, 2. 37*, 2. 58*, 2. 60*, 2. 59*, 2. 60*, 2. 56*, 2. 64*, 2. 62*, 2. 58*, 2. 60*, and 2. 61* mmol/l ,versus the expected vitros lac result 3. 96 mmol/l; pv2 lot m5007 vitros lac results 5. 09*, 2. 54* and 5. 19* mmol/l versus the expected vitros lac result 3. 76 mmol/l. Vitros lac lot 3531-0093-5063: pv1 lot l5005 vitros lac result 2. 13* mmol/l versus the expected vitros lac result 1. 39 mmol/l; pv2 lot m5007 vitros lac result 5. 67* mmol/l versus the expected vitros lac result 3. 33 mmol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected. There were no allegations of patient harm. This report is number four of twenty mdr's for this event. Twenty 3500a forms are being submitted for this event as twenty devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00097 |
| MDR Report Key | 6110944 |
| Date Received | 2016-11-17 |
| Date of Report | 2016-11-17 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-10-26 |
| Device Manufacturer Date | 2016-06-16 |
| Date Added to Maude | 2016-11-17 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 DIAGNOSTIC |
| Product Code | KHP |
| Date Received | 2016-11-17 |
| Catalog Number | 8433880 |
| Lot Number | 3530-0092-3271 |
| Device Expiration Date | 2017-12-01 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2016-11-17 |