MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANALYTICAL P MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number P MODULE

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: na.

Event Description

The customer stated that they received erroneous results for two patient samples tested for phos inorganic phosphorus (phos) on an analytical p module (modp) analyzer.The erroneous results were not reported outside of the laboratory and the repeat results were believed to be correct.The first sample initially resulted as 5.8 mg/dl.When repeated on a different analyzer, the result was 1.2 mg/dl.The second sample initially resulted as 5.2 mg/dl.When repeated on a different analyzer, the result was 1.2 mg/dl.The patients were not adversely affected.The phos r1 reagent lot number was 147818.The phos r3 reagent lot number was 155899.The reagent expiration dates were asked for, but not provided.The field service engineer determined that the analyzer was not washing and tubing was broken.He repaired the broken tubing.The account ran calibration and controls; all were within specifications.

Manufacturer Narrative

There have been no other events of the same nature at the customer site within the past 12 months.No abnormal trends were identified with the affected tubing found by the field service engineer in relation to complaints of high phos results.

• Brand Name: ANALYTICAL P MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6750110
• MDR Text Key: 81418809
• Report Number: 1823260-2017-01558
• Device Sequence Number: 0
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P MODULE
• Device Catalogue Number: 03738965001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 08/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR