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 2017-09-25 for COBAS 8000 C (701) MODULE C701 manufactured by Roche Diagnostics.
[89462938]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89462939]
The customer stated that they received erroneous results for three patient samples tested for ferr4 tina-quant ferritin gen. 4 (ferr) on a cobas 8000 c (701) module - c701. Of the three samples, two had erroneous initial ferr results that were reported outside of the laboratory. The first sample was run in a sample cup and initially resulted as 4. 4 ng/ml. The 4. 4 ng/ml value was reported outside of the laboratory as < 5 ng/ml. The doctor requested for a new sample to be collected from the patient. A new sample was collected from the patient on (b)(6) 2017 and tested, resulting as 21 ng/ml. The doctor then requested a repeat of the original sample. The original sample was repeated in a sample cup and it resulted as 20. 4 ng/ml on (b)(6) 2017. The original sample volume was observed to be low, it was hemolyzed, and contained debris. The sample was tested in a sample cup due to the low volume. The second sample, from an (b)(6) female patient born on (b)(6), initially resulted as 3. 90 ng/ml on (b)(6) 2017. The 3. 90 ng/ml value was reported outside of the laboratory as < 5 ng/ml. The doctor questioned the result, so the sample was repeated. The repeat result was 50. 1 ng/ml on(b)(6) 2017. The sample volume was very low. No adverse events were alleged. The ferr reagent lot number was 232970; the expiration date was not provided. The last calibration was performed on (b)(6) 2017 and was successful. Quality control results from (b)(6) 2017 are fine. The most likely root cause for the event is the low sample volume.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02057 |
| MDR Report Key | 6889499 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-09-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2017-09-25 |
| Model Number | C701 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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 | 2017-09-25 |