MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-17 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[65361612]
The investigation determined that lower than expected vitros dgxn results were obtained from a vitros quality control fluid in combination with a vitros 5600 integrated system. A definitive assignable cause could not be determined. An instrument related issue cannot be ruled out as a possible cause of the lower than expected vitros dgxn results. Historical dgxn quality control results indicate unacceptable within lab precision; however the immuno rate metering tubing was replaced on the vitros 5600 system prior to performing a within run vitros dgxn precision. Therefore a vitros 5600 system issue could not be confirmed as the cause of the lower than expected dgxn results. Vitros dgxn lot 1911-0240-5046 is no longer available for additional testing, therefore a reagent issue could not be ruled out as a contributor to the lower than expected dgxn results observed. The assignable cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[65361613]
A customer observed lower than expected vitros dgxn quality control results obtained from a vitros quality control fluid when using a vitros 5600 integrated system. Vitros dgxn results 1. 60, 1. 35, 1. 33 and 1. 13 ng/ml versus expected dgxn result 2. 13 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Ortho clinical diagnostics (ortho) has not been made aware of any erroneous vitros dgxn patient sample results obtained or reported from the laboratory during the time frame of this event, however, the investigation could not rule out that patient samples were not, or would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report is number one of four mdr? S for this event. Four 3500a forms are being submitted for this event as four devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2017-00010 |
| MDR Report Key | 6255267 |
| Date Received | 2017-01-17 |
| Date of Report | 2017-01-17 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2016-12-23 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2017-01-17 |
| 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 DGXN SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LFM |
| Date Received | 2017-01-17 |
| Catalog Number | 8343386 |
| Lot Number | 1911-0240-5046 |
| Device Expiration Date | 2017-02-01 |
| 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 | 2017-01-17 |