MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-08 for CREATINE KINASE 04524977190 manufactured by Roche Diagnostics.
[13161316]
Investigations were able to confirm the customer's ck results. A specific root cause could not be determined. The root cause of the lower concentration of ck was neither related to the hardware or to an interference. The root cause may be related to pre- analytic sample handling. Both sample types, serum and heparin plasma, are specified for both tests. K patient results are lower in heparin plasma samples could be explained in general by the different reference ranges for serum and plasma (serum: 3,5 - 5,01 mmol/l, plasma: 3,4 - 4,5 mmol/l). The root cause of the lower concentration of ckl was neither related to the hardware nor to an interference e. G. Heparin and might be related to pre- analytics.
Patient Sequence No: 1, Text Type: N, H10
[13278259]
The units of measure used for the ise potassium test are mmol/l.
Patient Sequence No: 1, Text Type: N, H10
[20126040]
The customer reported that they received erroneous creatine kinase (ck) and ion selective electrode (ise) potassium results when comparing the results from two different sample tubes from the same sample collection of the same patient. One tube was a serum tube and the other tube was a lithium heparin plasma tube. Both tubes were tested on a c501 analyzer. All results were reported outside of the laboratory. This medwatch will cover the ck test. Refer to the medwatch with patient identifier (b)(6) for information related to the ise potassium test. The serum tube initially resulted as 207 u/l for ck and 4. 38 for ise potassium. No units of measure were provided for the ise potassium test. A clarification has been requested. The lithium heparin plasma tube initially resulted as 138 u/l for ck and 3. 78 for ise potassium. The serum tube was repeated and resulted as 209 u/l for ck. The lithium heparin plasma tube was repeated and resulted as 146 u/l for ck. The lithium heparin plasma tube was repeated on (b)(6) 2015 and resulted as 134 u/l for ck. The field service representative replaced the gear pump head of the analyzer. It was noted that the gear pump head was in very good condition. The tubes were repeated after the gear pump head replacement on (b)(6) 2015. The lithium heparin plasma tube resulted as 138 u/l for ck and 5. 01 for ise potassium when repeated on (b)(6) 2015. The serum tube resulted as 201 u/l for ck when repeated on (b)(6) 2015. The serum tube resulted as 200 u/l for ck and 5. 37 for ise potassium when repeated for a second time on (b)(6) 2015. The patient was not adversely affected. The c501 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20185147]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-02830 |
| MDR Report Key | 4666826 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-08 |
| Date of Report | 2015-04-19 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-03-19 |
| Date Added to Maude | 2015-04-08 |
| 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 | 0 |
| 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 | CREATINE KINASE |
| Generic Name | DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHS |
| Date Received | 2015-04-08 |
| Model Number | NA |
| Catalog Number | 04524977190 |
| Lot Number | ASKU |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-08 |