MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-08 for CL-ELECTRODE GEN.2 04581008001 manufactured by Roche Diagnostics.
[49831515]
(b)(6). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[49831516]
The customer received questionable ion selective electrode (ise) chloride results for one patient and questioned if the medication chloral hydrate interfered with the results from the integra 800. A child was treated with chloral hydrate and while receiving the medication, the chloride result was 30 mmol/l higher on the integra 800 than the result received with another method. A specific result from the integra 800 was 146 mmol/l. The result in another lab, analyzed with "chloridmeter" was in the reference range. It was unclear if the same sample was used for both tests. The results were reported to the physician. Upon follow up, information was provided that the dosage of the medication had been decreased and now the results between the integra and chloridmeter agreed and were both within the reference range. The patient was not adversely affected and was in good condition. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. The dosage of the medication and the diagnosis of the patient were requested, but were unknown.
Patient Sequence No: 1, Text Type: D, B5
[54046317]
Upon further investigation, interference of chloralhydrate with the chloride results was found with integra chloride electrodes gen. 1 and gen. 2. In the indirect mode, the interference exceeded 10% of the measured chloride value for gen. 2 electrodes at chloralhydrate levels higher than 175 mg. In the direct mode, all tested chloralhydrate levels caused significant interference on all integra chloride electrodes.
Patient Sequence No: 1, Text Type: N, H10
[59241619]
Additional interference studies of chloral hydrate at different concentrations across the therapeutic range have been performed. No significant interference was observed. All similar product lines, including integra, were tested and no significant interference has been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00876 |
| MDR Report Key | 5778641 |
| Date Received | 2016-07-08 |
| Date of Report | 2016-11-04 |
| Date of Event | 2016-06-26 |
| Date Mfgr Received | 2016-06-27 |
| Date Added to Maude | 2016-07-08 |
| 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 | 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 | CL-ELECTRODE GEN.2 |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2016-07-08 |
| Model Number | NA |
| Catalog Number | 04581008001 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-07-08 |