MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-19 for PREA PREALBUMIN C502 20764655322 manufactured by Roche Diagnostics.
[95823058]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95823059]
The customer discovered questionable prea prealbumin (pab) results had been generated when they performed a reagent lot correlation. The results using the previous reagent lot were higher than the results using that reagent lot and a new reagent lot from a different analyzer. Of the data provided for two examples, only the results for one example were discrepant. The initial result was 75 mg/dl with the old reagent lot. This result was reported outside of the laboratory. On (b)(6) 2017, the result was 19 mg/dl for the same sample with the previous reagent lot and with the new reagent lot on a different analyzer. The customer corrected the result on (b)(6) 2017. The customer did not know of any adverse event for the patient. The previous reagent lot number was 19429601 with an expiration date of 31-jul-2018. The new reagent lot number was 24913401 with an expiration date of 31-mar-2019. The field service engineer (fse) could not find a cause. He checked the probe adjustment and rinse mechanism fluid levels and performed a precision check for pab that was within specification. He calibrated and ran quality control that was within specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-03026 |
| MDR Report Key | 7130650 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-19 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-04 |
| Date Mfgr Received | 2017-12-08 |
| Date Added to Maude | 2017-12-19 |
| 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 | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREA PREALBUMIN |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JZJ |
| Date Received | 2017-12-19 |
| Model Number | C502 |
| Catalog Number | 20764655322 |
| Lot Number | 19429601 |
| ID Number | NA |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-19 |