MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-06-24 for OMNI 03337154001 manufactured by Roche Diagnostics.
[18093617]
The customer complained of questionable results for 4 samples from newborn patients tested for calcium (ca) on a b221 analyzer. It was noted that 4 newborn patients were tested for ca and the results were below 0. 5 mmol/l after changing the electrodes. Of the data provided, 2 patient samples were erroneous. Patient 1 initial ca result was 0. 403 mmol/l. The patient was jittery. The patient's calcium injections were maintained. The ca test was repeated 3 times on the b221 analyzer with results of 0. 419 mmol/l, 0. 360 mmol/l and 0. 376 mmol/l. Patient 2 initial ca result was 0. 240 mmol/l. This result was considered to be low. The ca test was repeated 3 times on the b221 analyzer with results of 0. 240 mmol/l, 0. 236 mmol/l and 0. 225 mmol/l. The clinicians doubted the results from the b221 analyzer since patient 1 had been maintained on the maximum dose of calcium injections and both patients were clinically free on d2. Based on this, serum samples were obtained from both patients where patient 1 had a ca result of 1. 574 mmol/l and patient 2 had a ca result of 1. 548 mmol/l. No adverse events were reported. The ca electrode lot number and expiration date was not provided. It was noted that quality controls were acceptable after changing electrodes.
Patient Sequence No: 1, Text Type: D, B5
[18602051]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[32498100]
A specific root cause could not be identified. An instrument or electrode related issue was not identified. The investigation noted that the customer only ran 1 level of quality controls instead of the recommended 2 levels within 24 hours. The customer replaced the heparinized tubes and no further issues occurred afterwards. Based on the available data, the possible root causes may be that there was a low concentration of ica in the samples or pre-analytic issues caused the low results.
Patient Sequence No: 1, Text Type: N, H10
[32499941]
Patient 1 weight was provided as (b)(6); the unit of measure was not provided. Patient 2 is a male with a date of birth of (b)(6). Patient 2 weight was provided as (b)(6); the unit of measure was not provided. The patients were not adversely affected. The test being reported is ionized calcium (ica).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03709 |
| MDR Report Key | 4866790 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-06-24 |
| Date of Report | 2015-08-17 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-06-08 |
| Date Added to Maude | 2015-06-24 |
| 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 | OMNI |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2015-06-24 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-24 |