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 2015-08-20 for ANALYTICAL P MODULE 03284549001 manufactured by Roche Diagnostics.
[23864327]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[23864368]
The customer reported that they received an erroneous result for one patient sample tested for calcium. The customer stated that the calcium result was underestimated. The sample initially resulted as 9. 45 mg/dl on (b)(6) 2015. The customer had the impression that results were recovering low on (b)(6) 2015, so they repeated the sample to check. The sample was repeated on (b)(6) 2015, resulting as 7. 56 mg/dl. Both results were reported outside of the laboratory. The patient was not adversely affected. The calcium 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. Additional information required for the investigation was asked for, but not provided. Based on the provided information, a precision issue is apparent. Quality control fluctuations were observed in the provided data. A reagent issue can be excluded since successful calibrations were seen both before and after the incident occurred. The root cause of issue is assumed to be related to system maintenance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-03996 |
| MDR Report Key | 5019021 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-20 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-08-04 |
| Date Mfgr Received | 2015-08-04 |
| Date Added to Maude | 2015-08-20 |
| 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 | ANALYTICAL P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JFP |
| Date Received | 2015-08-20 |
| Model Number | NA |
| Catalog Number | 03284549001 |
| 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 P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-08-20 |
| Model Number | NA |
| Catalog Number | 03284549001 |
| 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 | 2015-08-20 |