MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-12-02 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[32577220]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32577221]
The customer received a questionable intact human chorionic gonadotropin plus the b-subunit (hcg+b) result for one patient sample. The initial result was 0. 100 miu/ml with a data flag. The sample was automatically repeated with a result of 634. 0 miu/ml. The patient sample was run for 3 different tests at the time of the event. 2 of the 3 tests received a sampling alarm and no results were generated. The initial hcg+b result was 0. 100 miu/ml with a data flag. The sample was immediately automatically repeated by the device with a result of 634. 0 miu/ml. The initial result was reported outside the laboratory to the fertility clinic. The customer stated that due to the result, the patient's hormone treatment was stopped and the fetus miscarried. The repeat result was believed to be correct. It was noted the customer's current process is to not hold results at the device but to transmit all test results, including initial and repeat testing results to the laboratory information system (lis). The customer then manually overrides the result and releases the result. The technologist in the lab released the result of 0. 100 miu/ml. The reagent lot number was 185430. The expiration date was requested, but was not provided. The field service representative could not find a cause. He verified the patient sample was automatically retested as expected due to the data flag. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. A possible root cause of the event was a sample related issue as noted by the sampling alarms that were received on the other two tests. Based on the information provided, no reagent or general instrument issues were identified. The device has a review by exception option that allows flagged results to be held at the device for review prior to transmission to the lis. The customer was not using this option at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-04666 |
| MDR Report Key | 5262275 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-02 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-11-03 |
| Date Mfgr Received | 2015-11-16 |
| Date Added to Maude | 2015-12-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 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 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NAL |
| Date Received | 2015-12-02 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-02 |