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 2017-05-17 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[75322461]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75322462]
The customer stated that they had been getting low results for an unspecified number of patient samples tested for alb2 albumin gen. 2 (alb) on a cobas 8000 c 702 module (c702) between (b)(6) 2017. The customer stated that the issue has occurred multiple times when the reagent pack has less than 60 tests remaining. Quality controls will drop out of range low, then samples are repeated on a different c702 analyzer with higher results. The customer now runs controls every 4 hours due to the issue. The issue occurs only on this analyzer line, but not on their other analyzer lines. The customer stated that approximately 50 sample results were corrected. The customer provided data for two patient samples that had questionable low results. Of these two samples, one had an erroneous initial alb result that was reported outside of the laboratory. The sample initially resulted as 1. 8 g/dl. The sample was repeated on a different c702 analyzer, resulting as 2. 5 g/dl. The repeat result was believed to be correct and a corrected report was issued. The patient was not adversely affected. The alb reagent lot number was 23085601, with an expiration date of 06/30/2018. The customer states that replacing the reagent pack resolves the issue and no re-calibration is necessary. The customer was not sure if the reagent probes had been replaced since the onset of the issue. The field service engineer suspects that there is an environmental issue with the reagent compartment of the analyzer. He checked pump pressures and pipetting; no issues were identified. Alb is the only assay affected on rotor b of the analyzer. He states that values recover lower when 1/3 of the reagent is remaining. The issue is not resolved upon multiple calibration attempts and quality control runs. Controls run on a fresh uncalibrated reagent pack recover near the mean. Probe adjustments did not resolve the issue. The temperature within the reagent compartment was good. Considerable condensation was visible within rotor b. He replaced an air pump diaphragm since a hole was found. He ran precision studies, yielding excellent results. No imprecision or pipetting failure was identified. The analyzer will be further monitored.
Patient Sequence No: 1, Text Type: D, B5
[78987424]
The customer stated that the issue started occurring on (b)(6) 2017. The issue occurred with both controls and patient samples only with certain reagent packs. The pack volume was typically around 60 tests when the issue occurred and remained until the pack was empty. The issue occurred 1-2 days after the pack was loaded on the analyzer. The issue was resolved once they started using a new pack. The customer tried using packs in multiple positions on the analyzer reagent rotor. The customer states that laboratory humidity and temperature were within specifications. The field service engineer also measured laboratory humidity and temperature. The customer has confirmed that the issue was resolved by the actions of the field service engineer. The customer has tried using multiple alb reagent packs and no further issues with recovery occurred. Investigations have determined that if condensed water drops into the reagent cassette, all reagents would have to be affected. The issue was resolved after replacement of the air pump diaphragm. It was concluded that preventive maintenance on the analyzer was not up to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01019 |
| MDR Report Key | 6571625 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-17 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-04-25 |
| Date Mfgr Received | 2017-04-25 |
| Date Added to Maude | 2017-05-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CJW |
| Date Received | 2017-05-17 |
| 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 | 2017-05-17 |
| 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 | 2017-05-17 |