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 2016-05-20 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[45650701]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45650702]
The customer stated that they received an erroneous result for one patient sample tested for intact human chorionic gonadotropin + the beta-subunit (hcgb). The sample initially resulted as 0. 100 miu/ml and this value was reported outside of the laboratory. The physician questioned the result since a urine pregnancy test performed on the patient 2 hours prior to sample collection was positive. The sample was repeated on the same analyzer, resulting as >10000 miu/ml accompanied by a data flag. The sample was then automatically repeated by the analyzer with a 1:100 dilution, resulting as 15074 miu/ml. The repeat result was believed to be correct. The patient was not adversely affected. The hcgb reagent lot number was 19028003, with an expiration date of 03/31/2017. The customer stated that they noticed possible "floaties" in the sample prior to repeat testing, but there were no alarms or messages from the analyzer at the time of initial testing. The field service representative could not determine a cause. He replaced the pinch valve tubing, cleaned and checked all probes and nozzles, and checked tubing connections. He verified that all tubing and connections were working properly. He ran performance testing and this was within specifications.
Patient Sequence No: 1, Text Type: D, B5
[46690068]
A specific root cause could not be determined based on the provided information. A possible root cause was fibrin or a clot in the patient sample. It was determined that centrifugation conditions of the sample were incorrect. No reagent or instrument issues were evident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00667 |
| MDR Report Key | 5669737 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-20 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-05-20 |
| 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 | 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 | 2016-05-20 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-05-20 |