MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANALYTICAL E MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable results for 15 patients for anti-hav (total antibodies (igm and igg) to the hepatitis a virus), 10 patients for cmv igg (igg antibodies to cytomegalovirus) and 13 patients for toxo igg (igg antibodies to toxoplasma gondii).Of the data provided, only the following results were discrepant.The samples were initially tested and the results reported outside the laboratory.Afterward the qc was out of range, so the customer repeated the patient samples on another modular analyzer.Data is initial result, followed by repeat result.Anti-hav (iu/l) patient 1: >60, 4.97.Patient 2: 28.46, <3.0 with a data flag.Patient 3: 31.3, <3.0 with a data flag.Patient 4: >60, <3.0.Patient 5: >60, 4.67.Patient 6: 41.25, 3.96.Patient 7: 47.67, 5.8.Patient 8: 33.06, 9.72.Patient 9: 24.53, 15.02.Patient 10: >60, 5.45.Patient 11: 57.95, 3.63.Patient 12: 58.44, <3.Patient 13: 26.25, 3.Patient 14: >60, 3.67.Patient 15: >60, 13.16.Cmv igg (u/ml) patient 1: 2.2, 0.150 with a data flag.Patient 2: 14.9, <0.150.Patient 3: 11.9, <0.150.Patient 4: 9.4, <0.150.Patient 5: 1.3, <0.150.Patient 6: 29, <0.150.Toxo igg (iu/ml) patient 1: 10.2, 0.304 or 0.340.Clarification of the repeat result was requested.Patient 2: 5.91,<0.130.Patient 3: 19.8, <0,130.Patient 4: 6.96, <0.150.Patient 5: 19.9, 0.3.Patient 6: 65.1, <0.130.Patient 7: 150.1, <0.130.Patient 8: 14.75, <0.130.Patient 9: 14.6, <0.13.Patient 10: 43.3, <0.130.Patient 11: 6.7, <0.130.Patient 12: 11.3, <0.130.Patient 13: 9.7, <0.130.The repeat results were believed to be correct.The reported results were corrected and communicated to some physicians by phone.The patients were not adversely affected.The anti-hav reagent lot number was 183935.The cmv igg reagent lot number was 181300.The toxo igg reagent lot number was 183495.The expiration dates were requested, but were not provided.The field service representative ran performance testing and it showed problem.The sample probe was removed and white crystallization was observed at the top when the top cover was removed.There was also yellow crystallization in the bottom of the probe.The field service representative changed the probe and repeated the performance testing with acceptable results.The qc was performed with results in the acceptable range.

Manufacturer Narrative

Clarification was received that the repeat toxo igg result for patient 1 was 0.340.

Manufacturer Narrative

A specific root cause could not be identified.The issues found by the field service representative, contamination, or an issues with the measuring cell were possible.Additional information for further investigation was requested but not provided.An issue with the measuring cell was considered most likely as no issues were reported until the measuring cell was replaced.

• Brand Name: ANALYTICAL E MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4996679
• MDR Text Key: 23424678
• Report Number: 1823260-2015-03957
• Device Sequence Number: 0
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 10/13/2015

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 Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• 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