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 2017-10-11 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[90182569]
(b)(4). The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90182570]
The customer complained of low gluc3 glucose hk gen. 3 results for 2 patient samples run on the cobas 8000 c 702 module. The results for both patient samples are a reportable malfunction. The glucose results the units were not provided. Patient #1 had an initial glucose result of 0. 00. The sample was repeated on another analyzer and a result of 4. 41 was obtained. Patient # 2 had an initial glucose result of 0. 02. The sample was repeated on another analyzer and a result of 6. 94 was obtained. For both patients the initial glucose results were reported outside of the laboratory. The ordering department questioned the initial glucose results as they considered them unbelievable. The repeat results were deemed to be correct. There was no allegation of an adverse event. The customer checked the initial analyzer and found no data or instrument alarms. Further investigation of the reaction monitors for the initial results showed that there was no sample added to the reaction cell pointing towards a sample aspiration error. The customer does not believe a contamination of the samples is likely as they manually pipetted the samples into false bottom tubes that were loaded into the appropriate sample rack type. The glucose reagent lot was 242156 with an expiration date that was not provided. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
[117871131]
Further investigation confirmed that the sample probes were not contaminated. The issue was mostly likely caused by a sample pipetting error but the specific root cause cannot be identified. The issue did not recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-02250 |
| MDR Report Key | 6939567 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-11 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-09-22 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-10-11 |
| 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 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFR |
| Date Received | 2017-10-11 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 |
| Brand Name | COBAS 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-10-11 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |