MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-14 for VITROS CHEMISTRY PRODUCTS PHBR SLIDES 8221384 manufactured by Ortho-clinical Diagnostics.
[3135809]
The customer obtained multiple, non-reproducible, unexpected, vitros phbr quality control results using two different vitros 5,1 fs chemistry systems. The following results were obtained: 5,1 fs #1: qc fluid biorad 1 = 16. 68 vs. An expected result = 13. 65 ng/ml; qc fluid biorad 2 = 33. 09, 37. 61, 21. 18 vs. An expected result = 52. 88 ng/ml; qc lot u2416 = 48. 2, 46. 1, 48. 5 vs. An expected result = 63. 52 ng/ml; 5,1 fs # 2: qc lot u2416 = 49. 5, 46. 3, 48. 2, 44. 4, 49. 3, 47. 8, 47. 2 vs. An expected result = 63. 52 ng/ml; biased results of the direction and magnitude observed may lead to inappropriate physician action if they were to occur undetected on patient samples. There was no report that patient samples were affected. There was no report of patient harm as a result of this event. This report is number fourteen of fourteen mdr's for this event. Fourteen 3500a forms are being submitted for this event as fourteen devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10458803]
The investigation determined that multiple, non-reproducible, unexpected, vitros phbr quality control results were predicted on two different vitros 5,1 fs chemistry systems. There is no evidence that an instrument related issue contributed to the event. Expected performance was achieved using an alternate reagent lot. The root cause of this event is a reagent related issue. Additional investigation by ocd regarding vitros phbr reagent performance is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2013-00078 |
| MDR Report Key | 2961810 |
| Report Source | 05 |
| Date Received | 2013-02-14 |
| Date of Report | 2013-02-14 |
| Date of Event | 2013-01-09 |
| Date Mfgr Received | 2013-01-16 |
| Device Manufacturer Date | 2012-10-18 |
| Date Added to Maude | 2013-04-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JOSEPH FALVO |
| 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 | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS PHBR SLIDES |
| Generic Name | IN-VITRO DIAGNOSTICS |
| Product Code | DLZ |
| Date Received | 2013-02-14 |
| Catalog Number | 8221384 |
| Lot Number | 2540-0063-3659 |
| Device Expiration Date | 2013-10-01 |
| 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 | 2013-02-14 |