MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-04-09 for OPTI CCA-TS2 OPTI 6 GD7046 manufactured by Opti Medical Systems Inc..
[5635877]
On (b)(6) 2015, opti medical confirmed a customer complaint from (b)(6). Customer reported positive bias between 5 g/dl to 7 g/dl in thb measurement relative to the pt's hematology results when using opti ts2 s/n (b)(4). There was no adverse impact to the pt's health condition due to this bias. The discrepant result from the analyzer was not used to make a med decision, e. G. Diagnosis or treatment. The dr indicated that the discrepant result was readily apparent and the pt blood retested using a different instrument.
Patient Sequence No: 1, Text Type: D, B5
[13213723]
The results of the tests from the hosp in (b)(6) were reviewed by opti investigation team. It is well understood that hemodialysis can affect thb. During review of the other blood results generated on the affected device, it was noted that the level of potassium measurement was high out of range in the first sample run. A high potassium level is consistent with blood samples that have hemolyzed. Sampling devices and loaner s/n (b)(4) were sent to the customer. The affected analyzer, s/n (b)(4), was returned to opti for investigation. The investigation of the issue using wider range of analyzers determined that some analyzers show a positive bias in the thb measurement that exceeds our specification at low so2 values. The investigation also concluded that the positive bias may be the result of a change in one of the components used in the thb measurement system of the analyzer. As part of the ongoing investigation, results from repeat tests run by the customer using appropriate sampling devices on s/n (b)(4) against i-strat reference and observed positive 2. 5 g/dl to 3. 5 g/dl bias on several samples on (b)(4) 2015. Opti technical personnel visited the hosp to observe the sampling and the testing was repeated on (b)(4) 2015. The positive bias was reproduced. Opti medical is initiating a field correction and removal customer notification in which customers will be requested to not report thb results when using opti cca-ts2 analyzer due to a positive bias in thb. Healthcare professional dr tim skelton (clinical pathologist) stated that a positive bias in thb result may lead to delayed treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004102403-2015-00001 |
| MDR Report Key | 4684334 |
| Report Source | 01,05,07 |
| Date Received | 2015-04-09 |
| Date of Report | 2015-04-09 |
| Date of Event | 2015-02-23 |
| Date Mfgr Received | 2015-03-11 |
| Device Manufacturer Date | 2014-08-19 |
| Date Added to Maude | 2015-05-26 |
| 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 | 0 |
| Manufacturer Contact | AGHASI CHITCHYAN |
| Manufacturer Street | 235 HEMBREE PARK DRIVE |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7706881723 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTI CCA-TS2 |
| Product Code | GKR |
| Date Received | 2015-04-09 |
| Model Number | OPTI 6 |
| Catalog Number | GD7046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OPTI MEDICAL SYSTEMS INC. |
| Manufacturer Address | 235 HEMBREE PARK DRIVE ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-09 |