MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-11-17 for ANALYTICAL E MODULE 03739040692 manufactured by Roche Diagnostics.
[31338008]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31338009]
The field application specialist first reported that he had been at this site on (b)(6)2015 to install the rbc folate application on the customer's analyzer. He said that he did not dilute controls for this test in the same manner as patient samples as directed. He stated that running the controls without dilution caused build up in the measuring cell of the analyzer. When the customer ran controls on (b)(6)2010, these were found to be out of range. The analyzer was not in use on (b)(6)2015 and (b)(6)2015. The field service representative checked the analyzer on (b)(6)2015 due to "abnormal measuring cell condition" errors that the customer had been getting. He determined that the analyzer high voltage was out of specification. He adjusted the high voltage so that it was within specifications. The customer ran calibrations and quality controls. After the service actions, the customer repeated approximately (b)(6) patient samples that were tested on (b)(6)2015. The customer mentioned that they issued corrected reports for a total of (b)(6) patient samples. Of the affected samples, the customer provided an example of one patient sample that had an erroneous vitamin b12 (b12) result. The sample initially resulted as approximately 705 pmol/l and this value was reported outside of the laboratory. The sample was repeated on (b)(6)2015, resulting as approximately 425 pmol/l. The repeat result was believed to be correct and a corrected report was issued. The patient was not adversely affected. The b12 reagent lot number and expiration date were asked for, but not provided. A specific root cause could not be determined based on the provided information. The most likely root cause would be related to mishandling of the quality control material. The quality control material could cause a contamination of the measuring cell, which could lead to a signal shift. The customer has not reported any further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-04565 |
| MDR Report Key | 5229244 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-17 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-11-02 |
| Date Added to Maude | 2015-11-17 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | ANALYTICAL E MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CGN |
| Date Received | 2015-11-17 |
| Model Number | NA |
| Catalog Number | 03739040692 |
| 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 |
| Brand Name | ANALYTICAL E MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-11-17 |
| Model Number | NA |
| Catalog Number | 03739040692 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-11-17 |