MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-27 for VITROS CHEMISTRRY PRODUCTS CALIBRATOR KIT 1 1882208 manufactured by Ortho-clinical Diagnostics.
[66237539]
The investigation determined that lower than expected vitros lac results were obtained from proficiency samples and non-vitros quality control fluids when using vitros chemistry products lac reagent in combination with a vitros 5,1fs chemistry system. The most likely assignable cause for the lower than expected results is the use of a sub-optimal calibration event. It is likely that user error in the preparation of calibrator fluids generated the suboptimal calibration event that lead to the lower than expected results. Following recalibration, an optimal calibration curve was obtained and there were no additional lower than expected results observed. There is no evidence that would indicate a vitros lac reagent lot issue or a vitros 5,1fs system transient malfunction
Patient Sequence No: 1, Text Type: N, H10
[66237540]
A customer obtained lower than expected lac results from proficiency samples and non-vitros quality control fluids results using vitros chemistry products lac reagent lot in combination with a vitros 5,1fs chemistry system. The following results breached vitros lac potential health and safety criteria: vitros lac result 3. 3 versus expected result 4. 81 mmol/l, vitros lac result 6. 3 versus expected result 7. 8 mmol/l, vitros lac result 2. 4 versus expected result 3. 71 mmol/l, vitros lac result 6. 4 versus expected result 7. 81 mmol/l, vitros lac result 2. 8 versus expected result 4. 35 mmol/l. Biorad l2 vitros lac results: 2. 02, 2. 06, 2. 01, 2. 06, 2. 05, 2. 03, 2. 02, 2. 11, 2. 10, 2. 10, 1. 66, 2. 05, 2. 12, 2. 11, 2. 14, 2. 09, 2. 12, 2. 08, 2. 08, 2. 07, 2. 08, and 2. 08 mmol/l versus expected 3. 49 mmol/l. Biorad l3 vitros lac results: 3. 76, 3. 81, 3. 75, 4. 03, 3. 94, 3. 87, 3. 84, 3. 76, 3. 86, 3. 89, 3. 96, 3. 90, 3. 85, 3. 82, 3. 85, 3. 84, and 3. 88 mmol/l versus expected 5. 63 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The customer stated that no patient samples were in question for vitros lac over the time frame of the event. 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 patient harm as a result of this event. This report corresponds to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00002 |
| MDR Report Key | 6283498 |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-27 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2017-01-04 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2017-01-27 |
| 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 CHEMISTRRY PRODUCTS CALIBRATOR KIT 1 |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | JIX |
| Date Received | 2017-01-27 |
| Catalog Number | 1882208 |
| Lot Number | 185 |
| Device Expiration Date | 2017-06-01 |
| 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 | 2017-01-27 |