MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[131340968]
The investigation concluded that multiple lower than expected vitros myog quality control results and multiple higher than expected vitros ckmb quality control results were obtained using non-vitros biorad quality control fluids in combination with a vitros 5600 integrated system. The assignable cause for the higher and lower than expected biorad qc fluid results could not be determined with the information provided by the customer. There was no evidence to suggest a vitros 5600 integrated system malfunction; however, it cannot be entirely ruled out as a contributing factor as the same quality control fluids generated acceptable results on an alternate vitros eci system on site. Additionally, based on multiple historical vitros reagent quality control results, and since the same reagent lots generated acceptable quality control results on an alternate vitros eci system, there is no indication a reagent related issue contributed to the event. Continual tracking and trending of complaints has not identified any signals that would point to potential systemic issues with vitros product ckmb, lot 2370 or myog lot 1365. Finally, it is unlikely a biorad quality control sample related issue as the same control fluids generated acceptable results on an alternate vitros eci system.
Patient Sequence No: 1, Text Type: N, H10
[131340969]
The investigation has determined that higher than expected vitros ckmb results were obtained from non-vitros biorad l1 qc fluid using vitros immunodiagnostics product ck-mb reagent on a vitros 5600 integrated system and lower than expected vitros myog results were obtained from a non-vitros biorad qc fluid using vitros immunodiagnostics product myoglobin reagent on a vitros 5600 integrated system. Biorad cardiac marker plus lot 23690 l1 qc fluid (ckmb) results of 4. 81, 4. 81, 4. 79, 4. 81 and 4. 87 ng/ml versus the expected result of 3. 026 ng/ml. Biorad cardiac marker plus lot 23690 l1 qc fluid (myog) results of 68. 49, 70. 30, 72. 68, 74. 55, 94. 93, 98. 74, 99. 25, 99. 81, 101. 83, 101. 83, 102. 72, 103. 78, 104. 04, 106. 31, 107. 05, 110. 14, 111. 28, 111. 48, 112. 23, 112. 62, 113. 0, 113. 98, 114. 38, 114. 43, 114. 93, 115. 84, 116. 55, 117. 28, 117. 92, 118. 42, 118. 89, 119. 31, 119. 85 and 120. 28 miu/ml versus the expected result of 131. 6 miu/ml. A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples. Ortho has not been made aware of any erroneous vitros myog or ckmb patient sample results obtained or reported from the laboratory over the time frame of the event; however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report is number two of two 3500a forms filed for this event, as two devices were affected. This report corresponds to ortho clinical diagnostics (ortho). Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2018-00199 |
| MDR Report Key | 8189986 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-02 |
| Date Mfgr Received | 2018-12-02 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2018-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | MR. JAMES A STEVENS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO CLINICAL DIAGNOSTICS |
| Manufacturer Street | FELINDRE MEADOWS PENCOED |
| Manufacturer City | BRIDGEND, WALES CF355PZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF35 5PZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2018-12-21 |
| Catalog Number | 6801042 |
| Lot Number | 1365 |
| Device Expiration Date | 2019-05-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-21 |