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 2016-10-31 for CA2 CALCIUM GEN.2 05168449190 manufactured by Roche Diagnostics.
[58828571]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58828572]
The customer complained of questionable ca2 calcium gen. 2 results from 1 patient when tested on cobas 8000 c701 analyzers. The initial serum sample was drawn as a pre-renal dialysis sample on (b)(6) 2016. The initial calcium was 1. 9 mg/dl. It was repeated on other c701 analyzers with comparable results. The specific results were requested but not provided. A second pre-dialysis serum sample was drawn on (b)(6) 2016 and produced a calcium result of 1. 6 mg/dl. It was also repeated other c701 analyzers with comparable results. The specific results were requested but not provided. A third pre-dialysis sample was drawn on (b)(6) 2016 at another facility (method unknown); the calcium was in the normal range. The patient was sent to dialysis. On about (b)(6) 2016 the customer pooled the small serum volumes remaining from the first 2 samples from (b)(6) 2016 (calcium of 1. 9 and 1. 6 mg/dl) and sent them to another laboratory where the pool was tested on a beckman au analyzer. The calcium was 5. 6 mg/dl on the pool. The customer received a post-dialysis lithium heparin sample drawn on (b)(6) 2016; the calcium result on the c701 analyzer was 8. 9 mg/dl. On (b)(6) 2016 serum and lithium heparin samples were drawn. The serum was tested on the c701 analyzer with a result of 5. 4 mg/dl. The lithium heparin sample was sent to another laboratory and tested by an unknown method with a result of 8. 1 mg/dl the patient was not adversely affected. One of the c701 analyzers had serial number (b)(4). The serial numbers of the other c701 analyzers were not provided.
Patient Sequence No: 1, Text Type: D, B5
[61628866]
The customer stated the next sample from the patient produced a normal calcium result (no data were provided), and said that, "... Whatever was interfering is out of the patient's system. " the customer refused further follow-up.
Patient Sequence No: 1, Text Type: N, H10
[65252606]
A specific root cause could not be determined with the information available. Additional information was requested but not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01678 |
| MDR Report Key | 6067298 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-31 |
| Date of Report | 2017-01-17 |
| Date of Event | 2016-10-03 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-10-31 |
| 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 | CA2 CALCIUM GEN.2 |
| Generic Name | TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM |
| Product Code | CHW |
| Date Received | 2016-10-31 |
| Model Number | NA |
| Catalog Number | 05168449190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-10-31 |