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 2018-03-13 for PHOS2 PHOSPHATE (INORGANIC) VER.2 05171377190 manufactured by Roche Diagnostics.
[102748787]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102748788]
The customer complained of discrepant results for multiple patients tested for phos2 phosphate (inorganic) ver. 2 (phos2) on a cobas 8000 c 702 module that started on (b)(6) 2018. Data was provided for 163 patient samples. The phos2 results for 46 patients were discrepant. The initial results had been reported outside of the laboratory. Following repeat testing, clinicians were contacted with the amended results. There was no allegation that an adverse event occurred. The c702 module serial number was not provided. The field service engineer (fse) had visited the customer site on 05-feb-2018 and all reagent and sample probes along with the gear pump head were replaced. On (b)(6) it was discovered that the ion blower had been turned off. This was turned back on. The customer thinks the issue was due to a particular reagent lot. The customer stated that every reagent pack that showed issues was from a delivery received on (b)(6) 2018 and put in use on (b)(6) 2018. All calibrations from 30-jan-2018 through 22-feb-2018 were done with the reagent lot in question (282314). Calibration errors were observed on (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018. All other calibrations seemed ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00806 |
| MDR Report Key | 7334077 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-02-10 |
| Date Mfgr Received | 2018-02-26 |
| Date Added to Maude | 2018-03-13 |
| 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 | 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 | PHOS2 PHOSPHATE (INORGANIC) VER.2 |
| Generic Name | PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS |
| Product Code | CEO |
| Date Received | 2018-03-13 |
| Model Number | NA |
| Catalog Number | 05171377190 |
| Lot Number | 282314 |
| ID Number | NA |
| Device Expiration Date | 2019-01-31 |
| 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 | 2018-03-13 |