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 2016-10-19 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[57927120]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57927121]
The customer complained of erroneous results for 1 infant patient tested for potassium (k) and hct on the cobas b 221 instrument. On (b)(6) 2016 the first k result was 7. 9 mmol/l. The second k result 10 -15 minutes later was 4. 2 mmol/l. On (b)(6) 2016 the first hct result was 4. 1%. The second hct result 10-15 minutes later was 10. 5%. The samples were arterial obtained by heparinized insulin syringes. No adverse event occurred. The customer indicated they had at least 10 patient samples that exhibited this behavior. The customer provided data for multiple patient samples tested for multiple parameters on the cobas b 221 instrument. Of the data provided an additional 6 patient ids were erroneous when tested for various parameters beginning on (b)(6) 2016. Refer to the attached data for the patient results. The k electrode lot number was 156687. The expiration date was not provided. No other lot numbers were provided.
Patient Sequence No: 1, Text Type: D, B5
[63730542]
The potassium electrode was returned for investigation. The lot number was 21553647. A preliminary check of the electrode showed a normal inner electrolyte fill level and the electrode was not damaged. This electrode was installed in a test unit used at the investigation site. Over the course of several days, the electrode was always calibrated and ready to perform measurements. Calibration and quality control (qc) measurements were acceptable. No other complaints for this issue have been identified for this lot number. Based on a review of the certificate of analysis, the "install before" date was 03/04/2016. With a typical "in-use" time of 26 weeks, the customer's potassium electrode expired on 09/02/2016. All calibration was acceptable on 09/30/2016, however qc had failed on 09/30/2016.
Patient Sequence No: 1, Text Type: N, H10
[68482548]
The customer provided additional erroneous results for the (b)(6) patient reported in the initial report. The customer stated this patient was also tested for thb at the time of the potassium and hct results. The 1st result was 4. 1 g/dl. The 2nd result was 10. 5 g/dl. The local support engineer could not find these results in the database of the instrument. Further investigation was performed on the potassium electrode returned by the customer. All prepared samples were within the specified ranges for potassium and hct. The potassium measurements with low and normal concentration showed an average difference of 0. 03 mmol/l and 0. 01 mmol/l respectively. The potassium measurements with high concentration showed an average difference of 0. 21 mmol/l. Measurements performed with low hct between 5-15% showed a difference of 0. 3%. During the investigation, the customer's alleged result discrepancy was not observed. A specific root cause could not be identified for this event. The customer's potassium electrode functioned as specified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01590 |
| MDR Report Key | 6040658 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-19 |
| Date of Report | 2018-04-04 |
| Date of Event | 2016-09-25 |
| Date Mfgr Received | 2016-09-30 |
| Date Added to Maude | 2016-10-19 |
| 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 | ROCHE OMNI S |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2016-10-19 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-19 |