MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-16 for C.F.A.S. PROTEINS 11355279216 manufactured by Roche Diagnostics.
[83305230]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4). Expiration date was provided as november 2018.
Patient Sequence No: 1, Text Type: N, H10
[83305271]
The customer stated that they received an erroneous result for one patient sample tested for aat2 tina-quant? 1-antitrypsin ver. 2 (aat) on a cobas 8000 c 702 module (c702). The customer complains about patient sample recovery with a new c. F. A. S. Proteins (cfas) calibrator lot number, 14434401. The customer ran a comparison of the old cfas calibrator lot (186510) to the new cfas lot using 40 patient samples. Patient samples were tested using the new calibrator lot on the c702 analyzer and the same samples were tested on a different analyzer using the old calibrator lot. The customer ran the samples on both analyzers within a short period of time. There was an 11. 5% difference in patient values when comparing the results obtained with the different calibrators. The customer is concerned because there is a direct relation between the aat results of patient samples and treatment that their patients receive. Of the 40 patient samples, one had an erroneous result. It was asked, but it is not known if the erroneous result was reported outside of the laboratory. The sample resulted with an aat value of 1. 23 g/l when tested on the c702 analyzer using the new calibrator lot. The sample resulted as 0. 86 g/l when tested on the other analyzer using the old calibrator lot. No adverse events were alleged to have occurred with the patient. The aat reagent lot number was asked for, but not provided. The c702 analyzer serial number was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01706 |
| MDR Report Key | 6797166 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-16 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-08-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | C.F.A.S. PROTEINS |
| Generic Name | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| Product Code | JIX |
| Date Received | 2017-08-16 |
| Model Number | NA |
| Catalog Number | 11355279216 |
| Lot Number | 14434401 |
| ID Number | NA |
| 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 | 2017-08-16 |