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 2016-05-27 for COBAS 8000 E602 MODULE 05990378001 manufactured by Roche Diagnostics.
[46071439]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46071440]
The customer stated that they received an erroneous result for one patient sample tested for intact human chorionic gonadotropin + the beta-subunit (hcg+b) on the e602 analyzer. The sample was initially tested and resulted with no value, only a data flag indicating that the reagent was short. The sample was repeated, resulting with a value 88. 83 iu/l. The 88. 83 iu/l value was reported to the doctor. The doctor informed the patient that she was not pregnant anymore, so the patient started smoking again and taking paracetamol. On (b)(6) 2016, the sample was repeated because there was a technical issue with the analyzer on (b)(6) 2016. The repeat result of the sample was 811 iu/l. The customer also provided data for an additional 42 patient samples tested for multiple assays. Of these additional samples, 7 had initial erroneous results that were reported outside of the laboratory for vitamin b12 (b12), ferritin (ferr), and hcg+b. The patients were not adversely affected. The hcg+b reagent lot number was provided as "0000000". The hcb+b reagent expiration date was asked for, but not provided. The lot numbers and expiration dates of the ferr and b12 reagents were asked for, but not provided. The customer stated that on the afternoon of (b)(6) 2016, the system had a reagent short alarm and several abnormal sipper movement alarms. The customer exchanged reagent bottles and found that there was air in the tubing and foam. The field service engineer found dirt in a syringe. He cleaned the syringes, cleaned tubing, and exchanged seals.
Patient Sequence No: 1, Text Type: D, B5
[46676516]
A specific root cause could not be determined based on the provided information. The issue with air in the tubing as observed by the customer indicates a leakage in the tubing. Air in the tubing can explain the observed issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00695 |
| MDR Report Key | 5684602 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-27 |
| Date of Report | 2016-06-07 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-05-13 |
| Date Added to Maude | 2016-05-27 |
| 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 8000 E602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NAL |
| Date Received | 2016-05-27 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 | 2016-05-27 |